chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a 20 years old female patient with anemia and asthma refers to herself. The patient was vaccinated with a dose of PNEUMOVAX23 (lot# and route unknown) and a dose of Influenza Virus Vaccine (manufacturer unknown) (lot# and route unknown) on the same day of an unknown date and had a bad allergic reaction(onset date reported as 25-OCT-2012). The concomitant medications were reported as steroids and antibiotics. The patient stated that she spent nine days at hospital. The patient stated her heart stopped, she had seizures, headaches and her liver enzymes were elevated(onset date reported as 25-OCT-2012). Lab information reported as cat scan, MRI(Magnetic Resonance Imaging), blood tests and heart sonogram. The outcome was reported as not recovered. Additional information has been requested.
they inadvertently gave an expired MENACTRA vaccine to a patient with no reported adverse event; Initial information received on 21-Jun-2022 regarding an unsolicited valid non-serious case received from nurse. GMI number: 01156569  This case involves a 20-year-old female patient to whom inadvertently expired Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra] vaccine was given with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In June 2019, the nurse inadvertently gave patient dose of suspect Menactra (lot U6952AA, expiry date: 09-Jun-2022) at (unknown: formulation, strength, dose, route, site) for prophylactic vaccination (expired product administered, same day latency).  It was reported that "nurse states they inadvertently gave an expired MENACTRA vaccine to a patient. Is this dose valid or what do they need to do at this point? MIA transferred nurse who asks if a dose of Menactra which expired 09JUN2022 would need to be repeated? This situation is reported as a medication error due to expired vaccine given".   Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the 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 guidelines. 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.
Covid arm- 2x3 inch raised red painful bump. Swelling itching sore no rash anywhere else.  Other side effects were fever & headache.
Each vaccine I have had which have all been Moderna, i have had a severe reaction. This third vaccine has been the most severe with severe flu symptoms; tiredness, severe muscle ache and still today I have a continuous pain in my left shoulder, weak, loss of energy, temperature.
This case was reported by a healthcare professional via a sales representative and described the occurrence of unspecified adverse event in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown) from lot number AFLL032AA. The sales representative reported the lot number to be AFL1A032AA but reported that he was unsure if the fourth character was a 1 or L. At an unspecified time after vaccination with FLULAVAL, the subject experienced unspecified adverse event and pharmaceutical product complaint. At the time of reporting the outcome of the unspecified adverse event was unspecified. Per the source document it was reported that the nurse questioned if "there were any hot lots." The nurse reported that she was not going to use any more FLULAVAL. It was noted that this was a legal case. The nurse reported that this event occurred in two other subjects. See GSK manufacturer case number A0705222A and A0705245A for details.
Soreness in arm for 3 days post vaccination. Soreness did not persist in other vaccines in the series.
fever; muscle ache; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (muscle ache), HEADACHE (headache) and NAUSEA (nausea) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history not reported.).    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PYREXIA (fever), MYALGIA (muscle ache), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, PYREXIA (fever), MYALGIA (muscle ache), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Body temperature: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient wanted to know if the side effects after first dose of Covid-19 vaccination were normal, if other people were experiencing it and how long would they last.  Treatment medication included Tylenol (acetaminophen).
passed out from exhaustion; Fever; was unable to stand unassisted.; writhing in pain/so much pain; in and out of consciousness/passed out; tongue swelled up, making it hard to breathe and impossible to speak; tongue swelled up, making it hard to breathe and impossible to speak; tongue swelled up, making it hard to breathe and impossible to speak; sweating profusely; couldn't support her own body without tipping over.; seizure; lymph nodes in her left armpit swelled up so much that she couldn't put her arm down without extreme pain; lymph nodes in her left armpit swelled up so much that she couldn't put her arm down without extreme pain; chills; extreme muscle pain; spasms; This is a spontaneous report from a non-contactable consumer (patient herself). A 29-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm on 02Apr2021 13:15 (Batch/Lot Number: ER8737) as single dose, for COVID-19 immunisation.  Medical history was reported as no. Patient did not have COVID-19 prior to vaccination. Patient did not receive other vaccines within 4 weeks prior to COVID-19 vaccine. Patient's concomitant medication includes omeprazole, ethinylestradiol, levonorgestrel (MARLISSA), venlafaxine and gabapentin from unspecified dates, received within 2 weeks of vaccination, for unspecified indication. Patient historically took first dose of Pfizer BNT162B2 (Lot number: EN6204) on 13Mar2021 at 11:00 AM on the left arm for COVID-19 immunisation. Patient previously took hydrocodone bitartrate, paracetamol (VICODIN) on an unspecified date and indication and had allergy. On 02Apr2021, around 10pm, patient began having chills and extreme muscle pain and spasms, and the lymph nodes in her left armpit swelled up so much that she couldn't put her arm down without extreme pain.  By midnight (03Apr2021 00:00), patient had a fever and was unable to stand unassisted. She was writhing in pain and arching uncontrollably off the bed.  She believed in hindsight that this was a seizure as she went in and out of consciousness and her tongue swelled up, making it hard to breathe and impossible to speak. She was sweating profusely, and had to drink water constantly.  Her husband had to help her get to the bathroom because she couldn't support her own body without tipping over.  The chills and fever alternated all night, and she finally passed out from exhaustion at 03Apr2021 at 7am. The next 2 days, she was in a cycle of fever and chills again, and the fever got so bad that she seized twice more on Saturday (03Apr2021).  She had to take the day off work on Monday (05Apr2021) as she was still in so much pain that she could barely leave bed except to use the bathroom. Events were reported as life-threatening, immediate risk of death from the events. Patient was not hospitalized. Treatment for the adverse events were cool baths, naproxen (ALEVE) for fever and pain, and PEDIALYTE. COVID-19 was not tested post vaccination. Vaccination facility type was at a hospital. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Hard area at site measures 50x58mm itching, slight pain. Noticed 24 hrs after vaccine given. Advised cold compresses, Benadryl lotion to site.
Vaccinated on 9/18/2018 and on 9/20/2018 reports that the injection area is red, warm, no itchiness, hardening. Referred to doctor.
Hospitalized (11.24.21; 11.29.21-12.3.21);  COVID-19 positive (11.18.21; 11.29.21);  fully vaccinated  Hospitalized 11.24.21 - Hospital (pt. sates that last night she began having a hard time catching her breath ; 94-year-old female with currently with Covid, with history of atrial fibrillation brought in by ambulance from her home with shortness of breath.  Worsened breathing started last night and continued throughout the day today.  Cough and congestion that she has had is actually getting better.   ED Course - The patient was staffed with Dr. who did not examine the patient.  She is in A. fib.  CBC unremarkable.  BMP with out any acute concerns.  Coags are normal.  D-dimer 0.91, age corrected is normal.  Initial troponin 40.4, 2-hour repeat 38.1.  proBNP 8305.  Chest x-ray with findings of COVID-19 pneumonia, no Congestive heart failure or effusion.  On repeat exam, found the patient to be having a panic attack.  I ordered 0.25 mg of Ativan IV but she refused the IV for nursing.  She did eventually calm down on her own.  She qualifies for monoclonal antibody therapy is that she is at day 10 today however she is refusing this infusion as well.  She is refusing admission to the hospital.  She signed out AGAINST MEDICAL ADVICE.  ED nurse has been in close contact with the patient's son who will be picking her up tonight.  She is instructed to return to the ER with worsening symptoms.  She should continue her aspirin daily.  Follow-up with primary doctor as soon as she is cleared of Covid.  She was agreeable with the plan.  Condition at Discharge:  Stable;  COVID-19 pneumonia, Anxiety, Atrial fibrillation, history of  Admission Date: 11/29/2021 Discharge Date: 12/3/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hyponatremia [E87.1] Weakness [R53.1]  HOSPITAL COURSE: Patient is a 94 year old female who presented with weakness and cough. She was COVID positive on 11/18 and had increasing weakness at home. She came to the ER for evaluation. In the ER she had a CXR showing right infrahilar opacities, her BNP was elevated at 3627 and her sodium was low at 120. Her procalcitonin was elevated and she was started on rocephin/azithro for CAP coverage. She was admitted to the hospitalist team for further management. Her sodium slowly improved with fluid restriction and salt tabs and she remained asymptomatic. She was given a prescription for salt tabs at discharge. She was given a prescription for ceftin to complete her course of antibiotics. Her cough improved throughout her stay. She was evaluated by PT/OT who recommended SAR. Rehab was arranged by care management. On the day of discharge the patient was feeling well and was eager to get to rehab. She will need follow up labs in the next 5-7 days to recheck her sodium level.
Rash, pimple like bumps, rough skin, severe itching .  Rash occurred with vaccine 1 and 2 , approximately  2+ weeks after vaccine.  Both reactions presented the same at onset: red raised rash on left side which developed some small pimple like lesions, raised, hard  bumps (itchy) at right back hairline,  rash ten spread to left back and right side with a lesser presentation.   First occurrence required physicians care.   Second occurrence was manageable with Benadryl, cortisone cream, and cool compress.   First occurrence treated with prednisone shot and pills. And a prescription steroid cream.   Marsh 8 reaction still being treated.
Syncope while seated; patient was placed on the floor with legs elevated. Provided food, water, and ice pack until felt better.
SEVERE LEG PAIN; TINGLING IN FEET, LEGS, ARMS, HANDS; NUMBNESS; SHOULDER PAIN; SUDDEN ARM PAIN/ CONSTANT PAIN/ HURT WHEN RECEIVED THE SHOT; ENLARGED LEFT SHOULDER/ SWELLING; STIFFNESS; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was left handed. The patient received vaccination with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 in total, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Dose number in series was 1. Concomitant medications were not reported. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced severe leg pain, tingling in feet, legs, arms, hands, and numbness for at least 3 months. The patient stated the vaccination did not go well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe leg pain, tingling in feet, legs, arms, hands, and numbness on an unspecified date in JUL-2021.  On 22-OCT-2021, the patient received additional non-company suspect vaccine mRNA 1273 (form of admin, route of admin, and batch number were not reported) dose was not reported, for prophylactic vaccination. Dose number in series was 2. As per the report, in the evening on 22-OCT-2021, following vaccination with mRNA 1273, the patients arm suddenly was in pain and had stiffness (not numbness). The patient stated that it hurt very much when patient received a shot. The patient remained in constant pain with an enlarged left shoulder. The patient did go to the physician and had an x-ray (results not reported). Per patient, the pain was in my shoulder and arm. At the time of this report, the patient was in too much pain.  The action taken with mRNA 1273 was not applicable. The patient had not recovered from sudden arm pain/ constant pain/ hurt when received the shot, shoulder pain, and enlarged left shoulder/ swelling, and the outcome of stiffness was not reported. This report was non-serious
2nd dose of Pfizer 12 and older given too early. 1st dose administered 08/10/2021 and second dose given 08/25/2021.
After a week the site where vaccine was given in the right shoulder became itchy, then swollen and warm and hard to touch. The next day this hasnt gone away yet and seems to have gotten bigger.
Day 3 post 1st dose of Covid Vaccine, child developed a circular rash around the waist, buttocks, and legs. Exacerbation of Eczema also observable. Child has severe itching boughts at night time before bed (not every night). Treated with Benadryl and topical creams. Doctors visit on Friday December 3rd, as rash appeared to be getting worse. Rash comes and goes, but appears to be a reaction usually at nighttime, and has appeared worse 2 weeks later. MD advised Zyrtec during the day and Benadryl at night while continuing topical Eucerin cream. No other treatment needed at this time.
The morning following the vaccine I woke with a very sore arm about 5AM.   My arm was tight and hard to lift or move behind my back as the day went on.   I used the internet to see if this was unusual, the site said you could have symptoms for up to 10 days, which was very rare, or two days following the injection.   As the days went on I have had less and less motion and more and more pain.   I cannot sleep through the night, I have a very difficult time driving, turning the wheel as well as backing up.   Yesterday, 10/4/20, I went back to the pharmacy and spoke with the pharmacist.   The pharmacist said I should file a complaint, as well as make an apt with my doctor.   The pharmacist also said this was much to long to be from the shot.   The pharmacist then asked where it hurt, when I showed her my shoulder area, she said "that is much to high for a shot".   When I asked if I could speak with the young man you gave me the shot, she said "he is no longer with the pharmacy.      I have made an apt with my doctor and will know more but this is absolutely without any doubt from the shot.     I am 65 on no medications, very healthy, play golf, tennis, ski, hike.    I currently am unable to lift my arm or pull it behind me.
My menstrual cycle has been very altered; period was very abundant; continued spotting till the 22May; This is a spontaneous report from a non-contactable consumer (patient) via COVAES. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 13May2021 at 16:30 (Batch/Lot Number: EW0168) (at the age of 30 years old) as dose 1, single for COVID-19 immunisation. Medical history included hypothyroidism. The patient was not pregnant at time of vaccination. The patient had no reported allergies. The patient did not undergo COVID-19 prior to vaccination. Concomitant medications included levothyroxine taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks of COVID-19 vaccine. The patient experienced menstrual cycle had been very altered, period was very abundant and continued spotting on 13May2021 at 18:00. The course of events was as follows: The patient's menstrual cycle had been very altered since her first shot. She had her period the day she had the 1st dose and that months period was very abundant (13May2021) and she continued spotting until the 22May2021 (her period usually lasts max. 5 days). The second period she had after second dose same problem (13Jun until 22Jun). This month she had spotting between cycles for 3 days (ovulation phase she believed) and she was spotting again the last 3 days. She already got an appointment with the doctor for next week. Is this normal? The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the event. The outcome of event spotting was recovered on 22May2021, while outcome of events menstrual cycle had been very altered and period was very abundant was unknown. The patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in Jun2021 (Batch/Lot Number: EW0217) administered in left arm for COVID-19 immunisation. The patient underwent laboratory tests and procedures which included PCR COVID test: negative on 10Jun2021 Nasal Swab.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning an 80 year old male who, about one week ago, on 23-MAR-2007 was vaccinated with varicella virus vaccine live (Oka/Merck). The physician reported, about one week post vaccination, that the patient has severe tendonitis, and is in a lot of pain, and needed a steroid injection. No other details provided. Additional information has been requested.
ADRENAL CARCINOMA; PANCREATIC CARCINOMA; LYNCH SYNDROME; This spontaneous report received from a patient via other manufacturer (Moderna) concerned an adult male of an unspecified race and ethnicity. 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, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, patient was diagnosed with pancreatic and adrenal carcinoma, and has upcoming surgery scheduled on MAY 08. He has a 2-gene variance, one gene has lynch syndrome, the other was undetermined. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the adrenal carcinoma, lynch syndrome and pancreatic carcinoma was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230464624- adrenal carcinoma, pancreatic carcinoma. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, considered indeterminate. The company causality is considered unassessable.
After the vaccine. I was sick with diarrhea for 4 days. And a lot of soft tissue pain, it caused my fibromyalgia to flare up. I had headaches, migraines. A week after the vaccine my left arm was hurting and it continues to hurt. It is worse at night and it will wake me up during the night. I let it go before I did anything about it. The 1st time I went to the doctor it was in  November 2021. He wanted to wait a while to see if it would get better on its own. He finally sent me for an x-ray for my shoulder and upper arm in January 2022. It did not show anything. The doctor thought it might be  SIRVA- which is a needle in the vaccine is put in the wrong place in the arm and causes damage to the tissue in the arm. Today, 03/23/2022-  I went for an MRI. I received the booster on 11/20/2021 on my left arm and the pain became worse.
After receiving vaccination, the patient became dizzy, nauseous, and developed a cold sweat.  Patient's mother gave him something to drink and patient started to improve during the waiting period after the shot.
resting heartrate was between 95 and 120 beats per minute with my blood pressure dropping to 90/50 with O2 saturation of 74%, along with flu like symptoms including fever of 102, chills, aches and a horrible headache. I experienced this for 2 days one of which I had to call in sick to work(Wednesday) off Thursday through Sunday.