chrisvoncsefalvay/vaers-outcomes huggingface dataset:
liquid was leaking from the injection site on the patients arm/no AE; quite a bit ran out of the injection site after the needle was withdrawn/no AE; Initial information was received on 19-Nov-2020 regarding an unsolicited valid non-serious case from a other healthcare professional.  This case involves an unknown demographics male patient for whom it was reported that the patient was extremely tense while vaccination and a liquid was leaking from the injection site on the patients arm (Exposure via skin contact) and quite a bit ran out of the injection site after the needle was withdrawn (Wrong technique in product usage process), while he received Influenza Quadrival A-B vaccine (Fluzone Quadrivalent).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reportd.  On an unknown date, the patient received a dose of suspect influenza quadrival a-b vaccine (Other dosing details were unknown, dosing interval twice, lot: UT7006MA expiry date: 30-Jun-2021) for prophylactic vaccination.  It was a case of actual medication error due to exposure via skin contact (latency: same day) and Wrong technique in product usage process.  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.
Left arm is swollen from her shoulder to her elbow, inflamed, hard to the touch and itching x 24-48hrs.
I tested positive for COVID-19 on 11/16/22. It felt like a bad cold. I can't recall my exact symptoms though. I wanted to take Paxlovid, but my doctor wouldn't let me take it because I am taking Eliquis. This lasted for about two days because I had Monoclonal Antibody Therapy.
Pt. states she had nerve pain following injection. Unsure when it started but it did cause her to "go to the hospital doctor" who told her it was not an allergic reaction but a neuropathy. Patient pointed to right forearm when asked the location of the pain. She decribed it as burning and tingling and lasted "about a week."
Herpes Zoster Ophthalmicus with Orbital Apex Syndrome/involvement of cranial nerves II, III, VI.
After the first shot I had horrendous uterine cramping. I was recently pregnant so it wasn't my period. The uterine cramping began at 0200 following my shot at 1200pm the day before. The cramping/stabbing feeling went on until the following afternoon. After the 2nd shot I experienced chest pain as well as pain in my left clavicle and shoulder. This was accompanied with a stomach ache and a generalized headache. This began at 2300 after my shot on that day and lasted until afternoon time the day after.
Arm/shoulder hurting, nausea, crying in pain. Advice - Ibuprofen/acetaminophen, fluids, rest, ice/heat.
This is a spontaneous report based on the information received by Pfizer from Merck & Co. Inc. (Manufacturer ref. number 00589602), by a contactable consumer (patient). This female patient of an unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, a couple days later administration of  vaccine, the patient developed cough which lasted about a year. The outcome of the event was unknown. No follow-up attempts possible. No further information expected.
2x2 cm non tender, warm, erythematous area on right upper arm surrounding injection site.
On March 8, 2021 at approximately 7:00 AM became ill with severe pain in all for extremities with feeling that each one of my cells was being attacked with severe burning and a red rash over my chest and face. Not able to function at all and was on bedrest for three - fours days. Not able to eat and became dizzy upon arising from bed, which was new. I thought I may die. I called my Primary Physician and was instructed if I became worse to let her know. Over the reminder of the week improved and I swore I would NEVER have another experiential mRNA injection.
"Horrible headache the first two days when waking up"; "Nausea for five days in the morning"; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE ("Horrible headache the first two days when waking up") and NAUSEA ("Nausea for five days in the morning") in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN for Cholesterol, FOLIC ACID for Folic acid supplementation, METHOTREXATE and HYDROXYCHLOROQUINE for Rheumatoid arthritis.  On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE ("Horrible headache the first two days when waking up") and NAUSEA ("Nausea for five days in the morning"). At the time of the report, HEADACHE ("Horrible headache the first two days when waking up") and NAUSEA ("Nausea for five days in the morning") 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.   The patient did not take any medications to treat the adverse effects she experienced after receiving the first dose of the Moderna COVID-19 vaccine, but she would like to take Tylenol or Excedrin if she experiences a worse headache after the second dose.
RED RASH WITH ITCHING RASH DEVELOP ON SHOULDER RASH THIS IMPROVING VACCINE SITE RASH STILL VISIBLE HAD A RAISED AREA ON FLU VACCINATION SITE AT SAME TIME
Information has been received from a health professional concerning a 7 year old male, with no pertinent medical history, drug reactions or allergies who on 22-AUG-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) (Lot #643086/0474M). There was no concomitant medication. On 26-SEP-2007, the patient developed a fever and the classic chickenpox vesicles. At the time of reporting the patient was not recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Large portion of dose leaked out; A spontaneous report was received from a healthcare professional (pharmacist) concerning a unknown age of unknown gender patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced large portion of dose leaked out. The patient's medical history, was not provided by the reporter. Concomitant medications were not reported. On unknown date, prior to  the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On unknown date , the patient reported large portion of dose leaked out. Treatment for the events were not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The events,large portion of dose leaked out was considered unknown.; Reporter's Comments: This report refers to a case of inappropriate dose administered for mRNA-1273 (Lot number: unknown) with no associated AEs.
Started with itchiness at the injection site the evening of the vaccine and raised areas on the arm (similar to sun poisoning / rash). The next morning both arms had raised areas. Within 3 days the raised areas looked like the "blisters" had popped with small open white patches (no fluid). Within 7 days the blister like areas were gone.
Pain in shoulder joint, waking her up at night.  Sought out care at chiropractor after stiff neck and back muscles around shoulder.  Numbness down arm into fingers.  Lost strength in arm.  Put on steroid from PCP, still feels numbness.  At least 5 other patients with similar symptoms after small flu clinic with same lot of flucelvax.
Patient father reported he passed away in his sleep the night of 06-07-21 and was pronounced diseased on 6-8-21
HEART ISSUE; BREATHING ISSUES; This spontaneous report received from a parent via a company representative via social media concerned a 38 year old male of unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient was previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin  not reported, batch number: unknown, expiry: unknown) dose not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin  not reported, batch number: unknown, expiry: unknown) dose not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced heart issue and breathing issues (Dose number in series 2). It was reported as "I know what you are saying my 38 year old son now has heart and breathing issues because of the shots too that he had to get for work or could not work there. He is still dealing with this and is still having chest pains and breathing issues." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from breathing issues, and heart issue. This report was non-serious.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 25-SEP-2015, the patient was vaccinated with a dose of improperly stored VAQTA (10Pk 50U/1 mL) lot number K008984, expiration date of 21-OCT-2015 (route of administration was not reported), which was stored 6 times with the following lowest recorded temperature: 34F (1.111 Celsius degrees) for 88 hours, 32 F (0 Celsius degrees) for 176 hours, 29 F (-1.666 Celsius degrees) for 120 hours, 31 F (-0.555 Celsius degrees) for 272 hours, 33 F (0.555 Celsius degrees) for 64 hours and 30F (-1.111 Celsius degrees) for 72 hours. No highest reported temperatures were reported. The type of storage was refrigerator. No concomitant therapies were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Soreness on the shot point, headache, fatigue, body ache for 48 hours
Patient received a first dose of Moderna vaccine on 2/9/2021. Patient was scheduled to receive their second dose on 3/9/2021 but was hospitalized. Patient was given a dose of Pfizer vaccine on 3/12/2021 as their second dose. Mixed series.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hashimoto's syndrome" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; FLUOXETINE; WELLBUTRIN; GABAPENTIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the event and the suspect drug BNT162B2 cannot be excluded.
Autonomic dysfunction; taking the shot my life has forever altered my life; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AUTONOMIC NERVOUS SYSTEM IMBALANCE (non-serious), outcome "unknown", described as "Autonomic dysfunction"; QUALITY OF LIFE DECREASED (non-serious), outcome "unknown", described as "taking the shot my life has forever altered my life". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: It was stated that, the patient was developed autonomic dysfunction since getting first pfizer shot. It was tested multiple times prior and during for covid and tested negative on multiple occasions, have lots of medical bills now and had not worked as a registered nurse for over 6 months. It was heartbreaking that for taking the shot for patient life has forever altered patient's life.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Raised area to right inner thigh, treated with Benadryl and cool compress. Resolved within an hour.
Given Moderna on 12/28/2020 second dose Moderna 1/25/2021 But Dx covid 19 on 3/19/2021
no problems w/vax even w/waiting; TC 1055 from dad pt fainted @ McDonalds didn't go clear out; eyes rolled back p/becoming pale; pt stated wanted to go home; felt better immed; did not eat breakfast; no n/v fluids & sugar; APAP to be given
After two hours, involuntary movements in hands and knees, dizziness. On the second day, my axilla on the left side swelled. Extreme tiredness and drowsiness that I still have to this day 08/28/2021. Changes in my menstrual cycles since the first month a few days and little spotting and now August did not come for the whole month. I have always had a regular seven day period. I also have a rash on the chest area.
Some to no feeling, numbness more so, at the tip of the 2 end fingers on the left hand, fingers gets irritated when I touch things. Swells. Looks red at the tip of the fingers. The outside of looks red and hurts.
Pt was vaccinated 11/5/17.  She reported she started to have rash on her chest/back and left arm 11/12/17. She was recently diagnosed with lymphoma but not on any medication or treatment for that.
On the day (6-19-2019) of the PCV13 injection, there was pain and swelling at the inject site (right upper arm) and I can't lift up the right arm.  Then at around 9 PM, very tired and felt I was running a fever.  I slept earlier than usual and still feel sick/running fever 10 am the next morning.  All these conditions/reactions remain as of the next day, 6/20/2019.
Patient had rash on injection site and back and around neck starting the day after vaccination. The rash on her arm went away. The rash on her neck is still very red and inflammed.
About 2 minutes after receiving the vaccine, while sitting upright in a chair, patient stated he felt like he might pass out and proceeded to become more limp, pale, and sweaty. His hands rhythmically twitched back and forth, and he dropped his phone. His eyes began to close, and his head leaned back. He remained upright in the chair. I elevated his feet in another chair, legs bent. I fanned his face/upper body and put wet papertowels on the back of his neck. After about 2 minutes, his LOC had returned to baseline. His color returned, and he stated he felt better after 5 minutes. He remained seated and sipped water for 30 minutes before going back to his office.
3pm vaccination. 4:30pm: onset HA, dizziness, chills. 7:30pm: onset nausea/ vomiting. 11:30pm onset cough, dyspnea, rapid heart beat. 1:00am: taken to hospital center ED with fever 101.5F. 2 "convulsions" in car on way to hospital.
local rxn lt deltoid muscle-site warm indurated about fifty cents size;rx advised to use heat off & on, Ibuprofen as needed;
Patient had normal discomfort after the shot.  helped family moving heavy items that day and next day and was sore afterward.  no issues until two days ago when he has started having burning in the area with use of his arm.  it is not happening constantly, just seldom with use of his left arm.
TREMORS, DIZZINES, PALPITATIONS, ANXIETY AND GENERAL WEAKNESS.
I had pain in my right shoulder and then about a week or two after that I started having pain in my muscles and joints. It was pain and stiffness throughout my right shoulders the to my calf, heels, foot or both of my legs. I waited a couple of weeks to see if it would go away. I couldn't raise my arm and it was painful. I had a Xray, and it showed nothing wrong. Then after being sent to a orthopedic doctor. I was having more pain increasing throughout my body. My PCP did order a bunch of lab work and stuff. Nothing was found in significance she everything looked good. Then after I saw her, she had me stop my Atorvastatin. After the Ortho doctor I was given a MRI of my shoulder. It showed a partial tear in my rotator cup, I received a cortisone injection in my shoulder and the pain went away in my shoulder and the rest of my body. He has now been about two weeks. My aches and pain in my body is coming back, but the shoulder pain is not. I going to contact my doctor this week.
two shots 8 weeks apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two shots 8 weeks apart) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two shots 8 weeks apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (two shots 8 weeks apart) outcome was unknown. Not Provided          Patient stated he received two shots 8 weeks apart: 28-Jan-2021 and 25-Mar-2021 (lot #047A21A). His wife also received her Moderna COVID-19 Vaccine more than 8 weeks apart (crosslinked MOD21-072052).
Child was ordered to receive Pediarix (Dtap+IVP+Hep B) as well as a HIB, PCV13 and rotavirus by physician. She was instead given Pediarix, PCV 13, Rotavirus and Hep B; thereby receiving two doses of Hep B at this visit rather than the HIB which was ordered. No additional treatment was needed.
Flu-like symptoms, muscle ache, starting late that night. Missed work on 9/24/00.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/16/21 (EN6200) COVID Positive 11/6/21  11/6/21: Patient is a 85 year old male who presented to ED via EMS with complaints of shortness of breath.  Patient has been experiencing increased shortness of breath since February of this year, with bilateral lower extremity swelling.  His symptoms have progressively worsened over the past several days. His daughter is at bedside and notes that he has had increased abdominal bloating for the past several days. He has had increased dyspnea with exertion and while lying flat.  He was seen by pulmonology October 24th with no definitive diagnosis for his fluid overload. He has been taking Lasix 20 mg daily. He had a high-resolution CT on November 5th which showed bilateral pleural effusions and pericardial effusion, with possible superimposed multilobar pneumonia or viral pneumonitis. He denies any recent fevers. He does endorse a productive cough with some mucus production, especially while lying flat.  He denies any recent nausea, vomiting or diarrhea. No chest pain.  He has been fully COVID-19 vaccinated.  He does not currently wear any home oxygen.  He has a past medical history significant for hyperlipidemia, BPH and history of PE anticoagulated on Eliquis.  On arrival to ED the patient was hypertensive 160/48 and hypoxic on room air at 87%.  The patient was put on 5 L nasal cannula with improvement oxygen saturations to 95%. Laboratory findings were significant for transaminitis AST 66 and ALP 192. Lactic acidosis 2.5.  ProBNP 772. Troponin 0.03.  Leukopenia 2.11.  Chest x-ray shows findings suggestive of CHF with bibasilar airspace disease most suggestive of pulmonary edema.  Rocephin and Zithromax were initiated in ED.  DuoNeb treatment given.  Lasix 40 mg IV given in ED.  11/27/21: An 85-year-old gentleman presented to the emergency room with worsening shortness of breath.  Patient reports some subjective fever.  He tested positive for COVID, eventually admitted COVID-19 pneumonia.  Patient was noted to be hypoxic, was treated with dexamethasone, remdesivir, empiric antibiotic therapy.  The patient's condition progressively improved.  Currently he is down to 3 L of oxygen via nasal cannula.  He is deconditioned, and will be discharged to skilled for further physical conditioning.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with expired dose of VARIVAX (Merck) (lot # H020671, exp. date: 14-NOV-2014) (dose, strength not reported). The reporter did not report any adverse experiences. Additional information has been requested.
No adverse event suffered. Due to improper record keeping upon the facility, the patient received a 3rd dose of a vaccine that only requires 2 doses.  Followed up with the facility to check on the patient after one day and after one week. no adverse events reported. Facility does not believe the patient received a third dose.
Information has been received from a physician concerning a 26 year old female patient who in October 2008 and December 2008 was vaccinated with the first and second dose of GARDASIL. Both times after receiving the vaccine the patient had vaginal discharge that went away in about a week. It was unknown if the patient sought medical attention. At the time of the report, the patient recovered. This is one of several reports from the same source. Additional information has been requested.