chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu-like symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). On 01-Mar-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.
Pt's mom called on 2/10/2000 at 10:50 AM, to report pt had rash that started 24 hours, post vax. It started on leg then went to feet and today, is on her trunk and arms. She is complaining of itching but has not called MD or given any medicines. Denies change in foods, detergents, etc. Instructed her to call MD for appointment and call nurse back after appointment. Doctor could not confirm if rash was an allergy to vaccine. He ordered Benadryl. Report from mother; rash almost resolved and had not given Benadryl yet.
Vaccine given too high, pain developed within 24 hours and I am now having limited range of motion as a result of pain
After the first dose, I had the usual tiredness and sore arm, I took Tylenol for the arm.  Two days later, I had an episode with my Afib being active (the propafenone had been managing this).  After my second dose, I had chills, low grade fever, feeling generally sick, all this was normal per CDC.  However, on the 19th I woke with full scale Atrial Fibrillation and my blood pressure was elevated.  Both kept rising until my BP was 173/108, I was very dizzy and faint.  I called 911, who transported me to Hospital ER (because my heart rate was extremely elevated and BP high).  My heart rate eventually went back to normal, BP still higher than it should be.  For the past week, my BP has fluctuated between being normal to being high.  The past two days, it has been normal.  The only explanation was a result of the 2nd vaccine as they could find no other problems in doing x-rays of my heart/lungs and blood work.  It was a bit scary because high blood pressure affects my kidneys and was the cause of the stroke in my eye last year.
Today during our morning vaccine clinic, we had seven patients here for their  second Covid- 19 Moderna vaccine. After the morning was over, I went to account for the vaccine left over. I then realized my count was off and the  only reason for that would be I gave one of the Moderna patients a Covid -19 Pfizer vaccine mistakenly. There is not a way for me to know which one it is, so I have listed all seven of them on the next page. I have been able to  contact three of them but not the four. I will send a letter to them.   The adverse event is just that. No reaction. One patient given the wrong  brand of Covid vaccine.  I will continue to contact patients I have not been able to.
The patient was brought to the ED by EMS on 2/6/23. Two days prior (2/4), she reported onset of generalized weakness and had a fall that day. She additionally reports nausea, vomiting, and shortness of breath that prompted her to come to the ED. EMS found the patient's O2 sats at 70% and so she was placed on 2L O2, and she had an O2 sat of 88% in ED triage. A COVID PCR done performed in the ED returned positive. She was admitted 2/6/23 - 2/11/23. Discharge diagnoses included severe sepsis, left lower lung bacterial pneumonia, severe COVID-19, and acute hypoxic respiratory failure. She was started on dexamethasone during admission. There was also concern for bacterial coinfection so she was started on treatment for community-acquired bacterial pneumonia. During her admission, she required up to 3L supplemental O2, but was able to be weaned off prior to discharge. Of note, she has received the primary COVID vaccine series and three boosters. Her most recent booster was administered 12/16/22.
10/11/2023 admitted with chest pain and diagnosed with pericarditis.  Started on aspirin and colchicine.  Was improving symptomatically. 10/18/2023 admitted with acute ischemic left MCA stroke.  Thrombectomy not successful.  Patient expired.
Diarrhea 8/31/22 at 1:00 AM. Redness, itching, induration at injection site beginning 9/1/22. Vomited x 1 on 9/1/22. Ongoing fatigue beginning on 8/31/22 . Intermittent shoulder and hip pain x 4 days beginning on 8/31/22. Sore throat x 1 day on 9/6/22.  Client stated inside of mouth was raw for one day on 9/6/22. Client complained of earache on 9/7/22 x 1 day.
slighty swollen sore arm with both vaccines; slighty swollen sore arm with both vaccines; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (slighty swollen sore arm with both vaccines) and VACCINATION SITE PAIN (slighty swollen sore arm with both vaccines) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Heart valve disorders and Overweight (slightly overweight).    On 19-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 VACCINATION SITE SWELLING (slighty swollen sore arm with both vaccines) and VACCINATION SITE PAIN (slighty swollen sore arm with both vaccines). At the time of the report, VACCINATION SITE SWELLING (slighty swollen sore arm with both vaccines) and VACCINATION SITE PAIN (slighty swollen sore arm with both vaccines) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-338018 (Patient Link).
Diagnosed with prolonged amenorrhea. Has had only one period on her own. She is 22 yrs old and now seeing fertility doctor.
NURSE GAVE A .6CC INJECTION WHEN ITSHOULD HAVE BEEN .3CC
Five minutes post vax, the infant developed an injection site reaction characterized by redness and rash. The infant recovered.
04/11/2022 Vaccination. 05/19/2022 I noticed during day, throat wasn't feeling right. Kept taking cough drops and affecting ability to talk, scratchy. 05/22/2022 COVID+
AS PER PATIENT INJECTION SITE WAS SWOLLEN AND ITHCY. SHE HAD HEADACHE FOR 3 DAYS WHICH WAS RESOLVED. ON 07/30/17 SHE WOKE UP WITH RASH ON HER UPPER RIGHT ARM AND RIGHT SIDE OF HER CHEST. IT IS ITCHY AND SHE APPLIED APPLE CIDER VINEGAR AND ITCH WAS RESOLVED WITH THAT.
01/05/2021 at 1451: Received Covid-19 Vaccine (Moderna) IM to L deltoid, during drive-thru 1512: Patient c/o feeling hot/flushed, confused/light-headed, states "heart racing." Appears pale in color. Patient was placed supine with legs elevated. BP 164/100, HR 94, RR 24, unable to determine O2sat, patient with gel manicure, would not register. Denies SOB. Denies chest pain. Patient remained A&O x4. Assisted and monitored by RN; second RN; third RN; and Fire Department. EMTs contacted. 1523: BP 142/86, HR 82, RR 20, color returned, A&O x4. Assited to sitting position. Reports "feeling better". Refused to go hospital/ER for further observation. 1523 patient contacted her father to come to Health Dept. to pick her up and take her home to avoid driving. Patient remained with RN until arrival of father. Fire Department remained with patient as well. 1545 Patient's father arrived to take her home, RN reports to writer that patient became SOB and light headed, and pain upon transfer to her father vehicle. EMS contacted, unable to obtain IV access x1 attempt. EMS placed patient on non rebreathing and transported to Emergency Department.
Patient was given the Pfizer covid vaccine at about 10:15 am on 8/17/21.   At approximately 10:30 am, she began to experience a bit of dizziness and felt hot.  The patient had not eaten breakfast.  We gave her several small pieces of chocolate, ice and water.  Also, a cool cloth was put on her head.   She did not feel better for about 15 minutes, but after that time, she stated that she felt better.  Her father was accompanying her.  He stated that he would watch after her and if her symptoms persisted or became worse, that he would take her to the emergency room.   I asked if he would like me to call EMS and he stated no, he would take her.
Pt became lightheaded, diaphoretic within 5 min of vaccination. Increase in anxiety. C/o SOB but able to move air without cyanosis, wheezing or stridor.
localized reaction 3 1/2 cm x 2 3/4 cm @ site of inject-red, hot, tender to touch; rx heat & APAP;
six small seizures; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received BNT162B2 (Lot Number: EL9264) via unspecified route on left arm single dose for COVID-19 immunization on 16Feb2021, 10:15 AM, at 75-year-old. Medical history included: hypertension, dementia, Lewy body dementia; known allergies: shrimp, coconut. The patient had not had COVID prior vaccination. Concomitant medication included: atorvastatin; donepezil; fish oil; fluticasone. No other vaccine received in four weeks. The patient experienced six small seizures on 19Feb2021, 04:30 PM, emergency room/department or urgent care visited and was reported hospitalized for one day. Treatment received included: a CAT scan, levetiracetam (KEPPRA). Outcome of the event was resolved.
Increased urination; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (Increased urination) 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 an unknown date, the patient experienced POLLAKIURIA (Increased urination). At the time of the report, POLLAKIURIA (Increased urination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.   Treatment information not reported.
I woke up with a tight and numb feeling on the right side of my mouth.  No blockage of airway or swelling inside of my mouth
The following day severe, debilitating headache, vomiting, diarrhea. Improved after one day, but lingering headache and gastro intestinal issues.  Was not able to eat for 48 hours.   Arm where injection received red, swollen, hurts, hot very large area (approximately the size of a softball or a bit larger in area).  Today is Tuesday, 8/31/21 and my arm is still swollen, red, hurts and hot.  That is 4 days.
Employee was given a concentrated dose of the COVID booster shot. 0.3mLs of vaccine were administer before being diluted. The vial is intended at a 6 dose vial. No adverse effects have been noted at this time.
After the first dose, the patient experienced lethargy, a low grade fever and a change in personality. After the second dose, the patient was immediately not feeling good and had difficulty breathing.
No additional adverse events reported; improperly stored vaccines may have been administered to patients; This spontaneous report has been received from a nurse, referring to a patient of unknown gender and age. Information about the patient's pertinent medical history, concurrent conditions, and previous drugs reactions or allergies were not provided.  On 13-DEC-2019, the patient was vaccinated with an improperly stored (product storage error), pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (Therapy type: Digital Data Logger), lot number S003872 and expiration date 22-DEC-2020 for prophylaxis (strength, dose, dose number, frequency, route of administration, and anatomical location, were not provided).  The vaccine was stored at a temperature above 47 degree Fahrenheit (47.1 Fahrenheit), for a timeframe of 8 to 16 minutes, with no previous temperature excursion. The call was due to a Digital Data Logger.  No additional adverse events were reported.  This case is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2001USA009007:
Fatigue and headache 24-72 hrs after injection.  On day 8 site of injection became red, swollen, hard and warm to touch
No additional AE reported; Caller stated a 51 year old female patient received the first dose of the vaccine on 08-APR-2021; This spontaneous report was received from a Nurse Prescriber concerning a 51-year-old female patient. Her concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported.  On 08-APR-2021, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 0.5 milliliter (mL) as prophylaxis (route of administration, lot number, expiration date and site of administration were not provided) (inappropriate age at vaccine administration). It was reported that the patient did not receive the second dose within the two month period. No adverse events were reported.
Immediately after injection the arm was sore and patient felt a sharp pain going up the right side of her neck (same side as vaccine).  Shortly after the neck pain the patient felt pain and weakness in her left jaw which increased over the day.  The pain diminished at night and returned each day increasing over the course of the day.  Over the past week the pain has been diminishing until the jaw is mildly sore to touch; patient denies any other symptoms.
administered ActHIB on 17MAR2023 that had diluent expiration date of 05MAR2023, with no adverse event; Initial information received on 29-Mar-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 60 years old male patient and reporter reported that he was administered HIB (PRP/T) vaccine [ACT-HIB] on 17-Mar-2023 that had diluent expiration date of 05-Mar-2023 with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  Concomitant medications included meningococcal vaccine A/C/Y/W CONJ (DIP TOX) (menactra) for Immunisation.  On 17-Mar-2023, the patient received 0.5 ml (milliliter) (1x) (once) of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection, (lot number: UJ649AAA, expiry date for powder: 03-Apr-2023 and expiry date for diluent: 05-Mar-2023) via intramuscular route in the left deltoid for immunization.  On 17-Mar-2023 the patient was administered HIB (PRP/T) vaccine that had diluent expiration date of 05-Mar-2023, with no adverse event (expired product administered) (latency: same day).  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for an event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
05/16/21 - vaccine administration 05/21/21 - small rash on inside right knee around 5pm; by 9pm, rash all over body.  Administered 1 Benadry tablet at 9:30pm. 05/22/21 - rash progressed; called pediatrician; administered 1 Zyrtek tablet. 05/23/21 - rash appeared to start subsiding.  Child reported some numbness in fingers and toes.  Administered 1 Zyrtek tablet. 05/24/21 - rash subsided significantly.  Swollen fingers and toes.  Administered topical itch cream. 05/25/21 - fully resolved.
I had a severe headache on the top of my head and sinus like symptoms. I had a fever that went up to 102 degrees. The next morning I went to the urgent care. They did a flu and COVID swab and they treated me for a sinus infection and gave me antibiotics. I didn't find out until later in the day that my COVID test was positive. I continued the antibiotics they gave me. The following Monday I called my doctor and had a Telehealth visit with her. She gave me prednisone which worked wonders. I was extremely tired and slept a lot. It never went into my chest. By the end of the following week I felt better.
This spontaneous report as received from a healthcare worker (certified medical assistant) refers to a patient of unknown age and gender. The healthcare worker reported that on 05-JUN-2014 a patient received an expired ROTATEQ (lot# H017721, expiration date 01-APR-2014, 2ml oral). Concomitant medications were not reported. No adverse effect reported. Additional information has been requested.
Information has been received from a medical assistant concerning a 61 year old male patient who on 09-JUN-2010 was vaccinated with a first dose of PNEUMOVAX 23 (Lot No. not reported). On an unspecified date, the patient experienced fever, headache, muscle aches and soreness at the site. It was unknown if the patient sought medical attention. At the time of the report, outcome for the events was unknown. This is one of several reports from the same source. Additional information has been requested.
One week after 1st shot I developed an itchy blistery rash on right eyelid.  Within days, I developed same vesicle rash on both elbows, was worse on left elbow. days later traveled to left side of left knee, and left side and behind right knee.  It has taken 6 weeks to clear up vesicles  using hydrocortisone and herbs from pharmacist.   I now am getting vesicles popping up all over my body as single vesicles.  My dermatologist biopsied one on my leg.  The result said I had an allergic response to "something".
Woke up with high fever (102+), felt lethargic, head ache, flu like symptoms, cold sweats, redness and tender at injection site, bruising and swelling, arm became swollen from elbow to shoulder, had large hardened area the size of a goose egg at the injection site that lasted for more than 8 weeks.
Dizziness, extreme sweating, fainted-loss of consciousness (unknown amount of time) Woke up somewhere between 7am - 8:30am and went into the bathroom.  Sat down on toilet and don't remember anything else. Spouse was woken up by pet barking and discovered me in the bathroom at 8:30am.  After about 20-30 seconds of saying my name, I woke up and, with his help, was able to walk back to bed. Laid down, was very warm, dizzy and sweating profusely. Drank some water and went back to sleep.
In 8/00, I received the 1st dose of Lymerix. Within 1 or 2 days, I was home in bed with nausea, fever, chills, aches and pains. They went away after a day or two. I thought it was a coincidence. In 9/00, I received a 2nd shot; did not experience any of the above (as I recall). In 11/00, my lower back pain had gotten bad enough that I was in the ER. The pain was so bad I could barely move. They felt it was a muscle strain and gave me some pain killers and told me to follow-up with my family doctor. She felt it was a strain and prescribed pain pills and either an anti-inflammatory or a muscle relaxer. In 5/01, my lower back pain has never gone away. On follow-up with my doctor, she ordered an MRI that showed some arthritis in my lower back. In 6/01, I was having a problem with my hands hurting a bit and going numb and returned to my family doctor. I had just returned from a week long fly fishing trip and she felt that the problem could be a bit of a Carpal Tunnel Syndrome. At the same time, she did some blood work that showed a problem with a liver function test. I believe she felt that the problem could be related to the Doxycycline I had been taking for many months as prescribed by a Dermatologist for rosacea. To be safe, she checked for Hepatitis which was also negative. The liver numbers have been checked quarterly and I believe are normal at this time. Spring, 2002, I started to experience a great deal of pain in my neck. It was difficult to sleep sometimes and hard to turn my head while driving. I could even hear the bones or cartilage cracking when I moved my head. I've been seeing an Orthopedic doctor for a badly sprained ankle since September. On a follow-up with him, I asked him about my neck. He felt it was a bit of arthritis and essentially said that until the pain starts to move down my arm, there was not a lot to be done. 8/02, I wasn't sure whether if I was due for another booster shot or not. I was due for another blood test to monitor the situation with my liver, so I looked on the internet regarding Lymerix to see how many boosters were required. That's when I saw the drug was off the market and there were potentially many problems associated with this vaccine. I went for my blood tests and met with the NP and told her of my concerns. She was not aware of any problems with Lymerix. She ordered additional blood work and a back X-ray. I dropped off some general information about what was going on. My regular doctor called me back, seemed grateful for the information, I dropped off and not only referred me to a rheumatologist, but called him to discuss my situation. I'm to see him in early September. Ongoing: I can't say when it started, but my shoulders, knees and hips seem to ache a lot more lately (at least the last year).
Information has been received from an office administrator via a field representative referring to a 16 year old female patient. No relevant medical history and drug allergy were reported. On 10-FEB-2015 the patient was vaccinated with her first dose of GARDASIL (lot# unknown), 0.5 ml, intramuscularly in the left deltoid. There was no concomitant medication. Prior to receiving the GARDASIL, the patient was in good health. When the dose of GARDASIL was administered to the patient, she felt dizzy or light-headed. Seven minutes later, the patient lost consciousness for approximately 20 minutes. The facility performed the following intervention to prevent serious criteria: they called 911, and the paramedics provided the intravenous fluid as treatment, and they also performed an electrocardiogram (EKG) as a diagnostic test (result unspecified). The patient was transported by the paramedics to an unspecified hospital on 10-FEB-2015. The representative did not know if the patient was observed overnight or admitted to the hospital. On 12-FEB-2015, the patient had an appointment to be examined by a Physician. The physician was reluctant to give her more doses of GARDASIL, so the representative did not know if the GARDASIL series were discontinued. The events of dizzy or light-headed and lost consciousness were reported to be serious as other medical significant. The outcome of feeling dizzy or light-headed was unknown. The relationship of the adverse events and GARDASIL was not reported. Additional information has been requested.
Pt admitted for 48 hrs due to rash on abdomen and buttocks, possible bacterial infection. Seen by ID and dermatologist, diagnosed with fixed drug reaction most likely due to the vaccine given prior to admission.
Edema/erythema of right anterior thigh 14x9cm about 3 days after.
Mother called to tell us the injection site was red and swollen. She said there is a hard circle where the injection went in. I recommended to continue using Motrin. Use a cold wash cloth on injection site.
pt recvd vax & w/in 15 min felt like "apple in throat"; was dizzy & could not breath;shaking,nauseated; took DPH,used inhaler;to er;tx w/ epi, tagamet,steroids; c/o headache & muscle aches next day;