chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist referring to a 72 year old male patient. Information about pertinent medical history, drug reactions or allergies and concomitant medication was unknown by the reporter. Historical drugs included PREVNAR 13 on 09-OCT-2015. On 18-FEB-2017, the patient was vaccinated with PNEUMOVAX23 (lot number, dosage information and anatomical site of vaccination were not reported) intramuscularly, for prophylaxis since the patient never had vaccination. Subsequently, on 18-FEB-2017, the patient developed "a big, hot red area extending away from the injection site" (injection site erythema). It was also reported that laboratory tests were not performed. No treatment was given for the adverse event. The patient contacted the pharmacist and sought medical attention. At the time of reporting, the outcome of injection site erythema was reported as not recovered. The causality assessment between injection site erythema and therapy with PNEUMOVAX23 was not provided. Additional information has been requested.
Chronic anxiety; Went berserk; This spontaneous case was reported by an other health care professional and describes the occurrence of ANXIETY (Chronic anxiety) and AFFECT LABILITY (Went berserk) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 ANXIETY (Chronic anxiety) and AFFECT LABILITY (Went berserk). At the time of the report, ANXIETY (Chronic anxiety) had not resolved and AFFECT LABILITY (Went berserk) outcome was unknown.        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.   Concomitant product use was not provided by the reporter. The patient took the Moderna Covid Vaccine and went berserk which started 3 months behind the Moderna Covid Vaccine. The patient was still on medication and that was been since Mar-2021. Now patient was on medications to sleep, on medication for anxiety. The patient had a real chronic anxiety that was ongoing for 3 months. patient was trying best to come off the medications. Patient was employed. Patient never had anything wrong with him, never been on a pill and now patient was on 3 different pills. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
I woke up noticed I was very weak. I stayed in bed, took Tylenol. I didn't go to my doctor, I just stayed in bed, drank fluids, and kept putting a warm towel on my injection site. My wife is a nurse so she took care of me.
She states she had a mild fever the first 2 days then developed diarrhea for many days after this.
3rd shot, booster on Nov 3rd.  11 days later on Nov 14th started getting hives all over body.  Swelling.  Itchyness.  Unable to sleep due to intense itchnyess.  Saw various allergists and even an ER visit when my face started swelling up.  Finally immunologist put me on high doses of zyrtec/pepsid + steroids seemed to control symptoms, although I still have swelling in my face and very sensitive skin (dermatographism)  Now, 3 weeks out from symptoms, a month since taking the 3rd booster shot, I'm still having the same symptoms, but managing with high doses of anti-histamines, steroids and a PPI.  If I stop the medication, I have itchyness, hives, swelling in hands and feet, face.
pt recv vax; w/ 24 hr post vax, devel swollen face; pt exp needle stick, source positive, and will be tx w/ HBIG; swollen face resolved;
Rash. Area red and hot to touch per telephone call 10-16-17 0836.
Patient has history of lymphoma, previous history of Covid pneumonia 9 months ago, fully vaccinated for COVID-19 and was admitted to the hospital 17 days peior with shortness of breath.  He was diagnosed with COVID-19 pneumonia.  Was started on heated flow due to significant hypoxia.  Patient was treated with with steroids, antibiotics, he was not given remdesivir due to the late presentation. Baricitinib given for few days, later on discontinued due to further elevation of his white count.  Had a CT of the chest that did not show any pulmonary embolus but multifocal pneumonia.  All respiratory measures have been tried and they have been not successful.  Patient requires supplemental oxygen of 3 l/min.  He is at his baseline functioning and ambulatory at home.  Patient requires oxygen via nasal cannula due to prolonged hypoxia.  He continued taking Bactrim and prednisone, and using his inhalers upon discharge.  Of note antibody were checked and they have been negative for Covid.
heart attack; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (death, medically significant), outcome "fatal", described as "heart attack". The patient date of death was unknown. Reported cause of death: "heart attack".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: heart attack
both shots were done on Fridays incase I got sick I had the weekend to recover First shot was just a feeling of muscle cramp and looked like a bee sting red bumpy around injection area and swollen not to bad but almost like a bee sting I only got like that with first dose not Second   Second shot was givin on Friday about 3:40ish I got symptoms the next morning exactly at 7 give or take couple minutes felt body aches fatigue weak body aches in hips neck lowback  arms got fever had chills I was covered head to toe socks hoodie even my head covered and still cldnt stop shivering body hurt and exactly at 11pm everything was gone like it never happen
START YESTERDAY WITH SMALL RED CIRCLE ABOUT THE SIZE OF A DIME, TODAY THE AREA IS 47MM AND WARM TO TOUCH. PATIENT STATES WAS ITCHING EARLIER, BUT NOT NOW. HAS USE ICE PACK AND WAS INSTRUCTED TO USE BENADRYL OR HYDROCORTISONE CREAM.
Vaccinator administered too deeply to achieve  a wheal.  Second attempt was a successful application.
10SEP93 pt vaxed w/Tetramune rt thigh & Orimune; pt exp 3 consecutive boils/purple eruptions @ the inject site; eruption disappears on it's own; each time spikes a fever of 103-104;
Pt reports passed out and hit the floor in the kitchen several hours after 2nd vaccination. She also had ear pain with yawning.
Red face, difficulty breathing and cough 4 minutes after vaccine administered. Epipen 0.3 mg administered at 1:58 pm Lot 026C20AA Expiration 02/2022. 1 puff ventolin administered 2:00 pm, EMS called, patient transported to Hospital at 2:08 pm.
This spontaneous report as received from a medical assistant refers to unspecified number patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or pertinent medical histories provided. On unknown dates, the patients were vaccinated with improperly stored PROQUAD lot # M044719, expiration date 07-MAY-2018 and lot# N014634, expiration date 07-NOV-2018. Concomitant therapies included properly stored sterile diluent. No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of -14 to - 10 degrees Celsius for 562 hours 16 minutes. There were previous temperature excursion. Digital data logger was involved. The outcome of incorrect product storage was unknown. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA008035.
Swelling, itching, redness (question possible hives) under bilateral axillae. No treatment. Outcome: fading rash over 3 weeks slowly.
1610 Patient complained of throat tightness.  Patient was diaphoretic.  169/115 HR 100, RR 32, spO2 98%.  1613 RRT called 1614 RRT at side.  right sided wheeze.  HR 80, BG 123, decision to transfer to ED   ED treatment. Decadron, benedryl, Pepcid IVP albuterol nebulizer
1407: Patient c/o extreme dizziness and weakness stating "feels like all of the energy left my body", BP 150/80, P121, O2 99, denies hx of hypertension and post injection reactions, nurse offered juice and will increase monitor time. 1420: BP 160/84, P 118, dizziness persisted and c/o heaviness in tongue lasting about 4 seconds. 1430: BP 164/82, P 122, O2 98, nurse encouraged patient to go to ER for further evaluation, patient refused ambulance and stated "I have to call my supervisor". 1447: Supervisor arrived, patient still c/o dizziness and "feeling weird" 1503: Supervisor and nurse escorted patient to security vehicle for safety, patient will go to ER. Cormier, Markus, RN 1/29/2021 08:37:21 AM > Contacted patie
Hospitalized 12/28/2021; COVID 19 positive 12/28/2021; fully vaccinated plus booster  BRIEF OVERVIEW: Discharge Provider:, MD Primary Care Provider at Discharge:  MD (Inactive) None Admission Date: 12/28/2021 Discharge Date: 1/10/2022 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute cystitis without hematuria Pneumonia due to COVID-19 virus  COVID-19    HOSPITAL COURSE : a 66-year-old woman with severe developmental delay, autistic disorder who resides at a residential facility, is nonverbal presented with hypoxia with onset of symptoms unclear.  Upon emergency department arrival blood pressure was labile, hypoxic requiring 2 L nasal cannula oxygen support.  Complete blood count showed lymphopenia and COVID testing positive.  Urinalysis showed pyuria and was given 1 g of IV Rocephin empirically presumed urinary tract infection at emergency department.   On admission, patient started on Decadron and continued 2 L nasal cannula oxygen support.  During the 1st 24 hours of stay patient had had episodes of hypotension and responded well with IV fluid bolus.  Also she was significantly lethargic that all her psych meds had been held.  With her EKG showing prolonged QTC.  Patient was placed on telemetry. After 48 hours of stay, patient's mentation significantly improved, she continued to saturate well at 2 L nasal cannula support.  She was initiated with remdesivir with planned completion of 5 doses.  Repeat QTC check had shown improvement that Seroquel dosing initiated with lower dose as well as her Depakote.  Continued Clonazepam and Topamax at her home dose.  Patient did well with all these medication dosing changes. She was the continued on a tapering dose of dexamethasone.   Patient continued improvement that she has been weaned off oxygen. PTOT evaluation did and recommended skilled nursing facility. With patient stable and safe discharge plans completed she was discharged to SAR stable on 1/10/21.
This is a non-serious spontaneous case from a consumer in  the USA involving difficulty breathing, the reporter causality is possibly related to FluMist. This case is submitted according to the VAERS Safety Surveillance accelerated reporting agreement for FluMist. A 48 year old female received FluMist on 10/19/2004. Approximately 4 hours later, the patient developed blisters in and around nose area and ear congestion, more on the right than the left. One to 2 weeks later, she experienced difficulty breathing which required two doctor visits where she received aerosol treatments. The patient also claimed she experienced depression at the time as well as had suicidal thoughts because she felt that she wasn't getting better. She had a history of Chronic Fatigue Syndrome, fibromyalgia, herpes simplex, and depression. The patient stated she has recovered from these reactions  except for the constant ear congestion.
I lost my voice completely, the lymph nodes were swollen and I had an extremely sore throat. I then developed cold symptoms and had such a dry cough that would not stop until I threw up. I saw two different doctors and was prescribed medication to help alleviate the coughing. I am now starting to feel better.
Varicella vaccine was administered after provider instructed me to since patient's titers were low. Previous varicella was given on 10/05/21, leaving only 9 days in between vaccines rather than the recommended 30 days. RN, Health Center Vaccine Coordinator notified, she will contact CDC for recommendations regarding any further need for vaccines.
pt recv vax 31MAR97 @ hlth dept;seen in office on 21APR97 w/documented chicken pox; (10-15 lesions so far);
Patient was given these vaccines on 9-21-22. They did not upload to system. When patient came into clinic on 10/21/22 he was given these vaccines again.  Mother of patient notified and states not adverse reaction.
After getting my first shot my arm was, felt like it swell which is normal; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration Date: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced after getting my first shot my arm was, felt like it swell which is normal. Consumer stated, "Ok, so what happened is after I got my COVID Vaccine technically is that when I got to feel like my arm was getting weak which is normal. What happened was after getting my first shot my arm was, felt like it swell which is normal but everything was kind of like okay, after 2 or 3 days my arm was kind of like okay, everybody was like it's going to go away. The clinical outcome of the after getting my first shot my arm was, felt like it swell which is normal as recovered.  Further information could not be probed as the consumer was unwilling to share any further information. Hence limited information available over the call.  Information on the lot/batch number has been requested.
A report has been received from a Health Professional concerning a 69 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that the patient inadvertently administered FLUMIST QUADRIVALENT to a 69 year old patient which started on 16-Sep-2014. The outcome of the event of inadvertently administered FLUMIST QUADRIVALENT to a 69 year old patient is unknown. the report was considered to be non-serious.
Fever; chills; nausea; injection site pain; body aches; This is a spontaneous report from a contactable nurse (patient). A 33-year-old female patient (no pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Ek5730) via an unspecified route of administration on 22Dec2020 06:45 PM on left arm at single dose for COVID-19 immunization. The patient's medical history included chronic low back pain and not allergy to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The concomitant drug was not reported. The patient experienced fever, chills, body aches, nausea, injection site pain on 23Dec2020 11:30 AM. No treatment for adverse events. The outcome of the events was recovering.
No adverse effects; The patient was vaccinated with improperly stored VARIVAX; This spontaneous report was received from a nurse and refers to a 3 unspecified patients of unknown age and gender. The patients' medical history, concomitant medications, drug reactions or allergies were not reported.  On 07-AUG-2019, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, lot # R031626, expiration date: 01-NOV-2020 (strength, route of administration and anatomical location were not provided) for prophylaxis. Temperature excursion was 11. Fahrenheit (F) during a time frame of 1 hour and 36 minutes which was recorded by a data logger. No previous temperature excursions were involved. No adverse effects were reported.   Follow up information was received form the nurse concerning a 4 years old male patient on 15-AUG-2019.   Patient demographics were updated.   On 07-AUG-2019, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX), subcutaneously, lot number R031626, expiration date: 01-NOV-2020 in the right arm (strength was not reported) for prophylaxis.   The reporter stated that three doses of varicella virus vaccine live (oka/merck)(VARIVAX) were accidentally administered before realized the digital data logger noted an out of range temperature. Upon realized the out of range temperature measures were taken to address it staff was educated on excursion process and ways to prevent this from happening in the future.  This is one of three cases received by the same reporter. ; Sender's Comments:  US-009507513-1908USA004291: US-009507513-1908USA006568:
the booster dose was expired, two weeks prior.; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the booster dose was expired, two weeks prior.) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (the booster dose was expired, two weeks prior.). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (the booster dose was expired, two weeks prior.) had resolved.            No concomitant medications was reported. No treatment drug details was reported.
pt noticed pain (L) arm - posterior to deltoid. Felt a vibration like sensation when the needle was injected into (L) upper arm. By end of day, arm was extremely sore. Woke up in middle of night several times w/ pain + having difficulty raising arm. Pain has improved w/Aleve + ice w/in 48-72 hrs but pain persists mostly at night + in early am.
Information has been received from a physician concerning a 17 year old female who on 10-JUL-2007 was vaccinated with a first dose of Gardasil. Concomitant therapy on 10-JUL-2007 included DTaP, tetanus toxoid and Vaqta. On 10-JUL-2007 after the vaccination, the patient was seated for several minutes. When the patient got up to make an appointment, the patient fainted, hit the floor and had a knot on her head. The physician referred the patient to the hospital for the skull X-Rays, results were reported as negative.  At the time of the report the patient was recovering. The physician considered fainting, hitting the floor and had a knot on her head to be an other important medical event. Additional information has been requested.
I had a sore throat runny nose body aches and low-grade fever. I treated myself with aspirin. that did help. I contacted a doctor, and I was told to come in for a PCR test was given PAXLOVID I took the medication as prescribed, and I started to recover.
Client  received the 1st dose of Pfizer COVID vaccine (lot #ER8737 expiration date 4/3/21). Client had completed 15 minute observation when she reported feeling a warm sensation starting in her chest and spreading up to her throat to EMT. At 1215 EMT took first set of vitals: Heart rate 76, blood pressure 120/80, oxygen saturation 100%. Client denied shortness of breath, no swelling, no redness of skin. Per client history of anxiety and allergic to certain fruits. EMT stayed with client and gave water. Vitals at 1234: heart rate 69, blood pressure 130/90 and oxygen saturation 99%. Client reported symptoms improving. Client asked to stay an additional 15 minutes in observation. EMT  informed lead PHN at 1238 and PHN went to assess client. Upon arrival client alert and oriented. Stated had warm sensation from chest to throat that had already resolved. Client denied shortness of breath, chest pain, no swelling noted. Client stated feeling better and was ready to go home. Last set of vitals at 12:42PM: heart rate 65, blood pressure 126/82. Client advised to speak to provider before second dose. ER precautions also given. Client left facility at 1240 with steady gait.
A little black dot in her left eye/like "broken blood vessels/ the veins are floating around"/Felt like something burst in her left eye; left eye felt like something was in it/ dot is moving around my eyeball/Every time she rolls her eye it is like something is stuck; left eye kind of felt like she had something in it, like a blood clot, there was a little dot there; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm (also reported as 'left shoulder upper arm') on 21Jul2021 13:00 (Batch/Lot number was not reported) at the age of 65 years, as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported. The patient's mom had Alzheimer's, and her dad had heart attack. Concomitant medications included ongoing colecalciferol (VIT D) and ongoing regular multivitamin, both taken for an unspecified indication. The patient did not receive additional vaccines on same date of or within four weeks prior the Pfizer suspect. She does not ever get vaccines, does not get the flu shot and has never had the flu. The patient reported that she feels like something burst in her left eye. On 23Jul2021 around 07:00, she woke up because her left eye kind of felt like she had something in it, like a blood clot, there was a little dot there. She initially thought maybe she had dust or something in her eye so she rinsed her eye out with some eye drops (Lot: XD747, Expiry: Aug2023) and then went shopping but that didn't work. Every time she rolls her eye it was like something is stuck on there, looks like. She doesn't know, but like blood. When she returned home, around 11:00 am, the dot was still there, but smaller and it had kind of spread. It's now broken up like veins but at first it just started as just as little dot; that's why she thought maybe there was lint or something in her eye; but now it's like something burst, and she can see a little trail or something now. There's like "broken blood vessels/ the veins are floating around and the dot is moving around her eyeball when she reads or looks out her left eye." She called her Optometrist and is going to go in today to have her look at it, but has not had any physician's office visit, emergency room visit or hospitalization as of yet regarding this event. She called to ask if any other reports of side effects have been made like this with Pfizer-BioNTech Covid-19 Vaccine. She was on the fence about getting the Pfizer Covid vaccine and didn't want to take it, and now she was frustrated because of her left eye having problems. Outcome of the events was not recovered. The patient reported the events as non-serious.  Information about lot/batch number has been requested.
Chills, sweats, dry mouth, nausea, diarrhea, body aches, migraines, eye burning, couldn?t put weight on injected arm, new loss of smell, vertigo
Patient wanted the Shingles shot but unfortunately got the Covid shot. The Immunization Alert system checked before administration showed no records of a previous Covid shot. But after the shot patient presented us with his CDC card showing the Covid series completed in March 2021. He was ok. We informed his doctor on June 10th and upon follow up with patient he said his body temperature was very low and he had pain in his joints.