chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 24 month old female pt who on 19May04 was vaccinated with varicella virus vaccine live. On 10May05 the pt developed breakthrough. The physician described her breakthrough as a very mild case with only a few lesions (less than 50). At the time of this report the pt was recovering. There was no product quality complaint reported. The reporter mentioned that the pt's sister who was previously vaccinated with varicella virus vaccine live also developed breakthrough (WAES0505USA01850). Additional information has been requested.
major arm pain in arm that received injection. Woke up at 4:30 AM the night of vaccine (~12 hours later) with nausea and severe arm pain. Took pepto bismol and pain medicine to go back to sleep. Nausea persisted throughout the next day when I woke up (16 hour mark). Severe fatigue throughout the next day - had to sleep all day. Headache and arm pain / body aches continued. Chills began around 8pm (27 hours)
2 or 3 wks after the vaccine his  blood pressure was high and his heartbeat rate number was going up
she has pain in the left arm where the injection was given; could not move her arm she had to use her opposite arm to lift her arm; This is a spontaneous report from a contactable registered nurse (patient, reported for herself). A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration in left arm on 27Jan2021 as single dose for covid-19 immunization. Medical history included ongoing migraine. The patient's concomitant medications were not reported. In Jan2021, the patient has pain in the left arm where the injection was given, could not move her arm she had to use her opposite arm to lift her arm. It was unknown whether the reporter was a healthcare professional or prescribing HCP. The reporter's contact information was available to a sub-contracted party. Patient reported that she has a history of migraines. Patient would like to know if it would be safe to take Imitrex, Sumatriptan, Eliquis, Propranolol, Crestor and Rosuvastatin after taking the Pfizer COVID vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (28Jan2021): This is a Follow-up spontaneous report from a Pfizer-sponsored program. A contactable Nurse reported that: Caller has received vaccine and wants to know if she can take Imitrex.  Follow-up attempts were completed. No further information was expected.
Vaccinee experienced malaise, chills, sweats, body aches, diarrhea (resolved), fevers & flu like sx 1 wk beyond 1st inject 20SEP90; Sx persisting for 3 wks. No tx has been given.
Flublok quadrivalent administered to a 17 year old inadvertently with no adverse event; Initial information received on 16-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 17 years old female patient who inadvertently received 0.5 ml dose of an INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: UJ446AA, expiry date: 18-Mar-2021) via intramuscular route on right arm on an unknown date for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  It was an actual medication error due to Inappropriate age at vaccine administration. (latency- same day)  At the time of reporting, patient had not experienced any adverse 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 Directive and Module VI of the 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.
Throbbing & bleeding gums, dizziness, complete face numbness, difficulty breathing, throat closing up, elevated & pounding heart rate, arm & feet numbness & tingling, fever, hives, tongue numbness, elevated blood pressure.
Four (4) hours after injection experience pain and stiffness in upper left arm from shoulder to elbow with limited range of motion.  Took ibuprofen and rubbed in Deep Blue before bed.  Did not sleep well.  Symptoms started to improve about 9:00 a.m. 10/8/2020.  Called pharmacy to report and they have called back twice since then.  48 hours after injection only a very slight pain when are was extended at full range of motion.  No symptoms 72 hours after.  (Have never had any reactions to high dose influenza before this year.)
Anticipating a reaction I took Zyrtec and received the Pfizer booster. Was "fine" that day. The following morning  I stopped taking Zyrtec. By midday I was covered with red, itchy welts all over my body and I dealt with wheezing. Went back on Zyrtec. It's day five and I'm still itchy but the red welts are starting to dissipate.   On April 2 2021 I received the J & J vaccine and was covered with red welts all over, for five days. I was hot to the touch but it was not itchy, nor did I experience respiratory issues. Stayed in bed taking Benadryl every few hours.
04/23 - Heart Palpitations and Extreme Dizziness/Confusion 04/24 - Miraine Kicked in (Had Migraines before) 04/31 - 05/17 - Heart Palpitations come back for a day, go away, come back for a day. Dizziness/Brain Fog/Confusion is maintained the entire time. A few intense bouts of dizziness in public that feel like Panic attacks. Chest pains throughout this time as well. 05/18 - 05/30 - Heart Palpitations mostly gone, Dizziness and Brain Fog linger but appear to be managable.
Starting after new year?s, I developed a cough. It was a wet cough and I had a sinus infection also at the same time. All of this lasted for a month, I went to a urgent care and regular doctor. She prescribed medications for me. It took a while, but it helped. I got different antibiotics and inhalers from the urgent care and my doctor. February I was still sick and seen my doctor a couple of times. I was just given another inhaler and told I had a mild case of COPD. I feel okay now.
Three days of high fever (102.6 at its highest). Delirium.  Body aches, chills, headaches, stuffy nose and sinuses, bad cough, flem and loss of appetite. Treatment: regular administration of tylenol, fluids. My wife and a good friend have had similar reactions.
Admission Date: 7/20/2022  PRESENTING PROBLEM: Gross hematuria [R31.0] Bilateral pleural effusion [J90] Acute cystitis with hematuria [N30.01] Acute diastolic CHF (congestive heart failure) (HCC) [I50.31] Renal carcinoma, right (HCC) [C64.1] Adenocarcinoma of left lung (HCC) [C34.92] Atrial flutter, unspecified type (HCC) [I48.92] Acute congestive heart failure, unspecified heart failure type (HCC) [I50.9] Acute on chronic blood loss anemia [D62]   HOSPITAL COURSE: Patient is an 86 year old male with PMHx of severe pulmonary hypertension, chronic right sided heart failure, CKD3, DM2, COPD on home 2L O2, renal carcinoma who presented to the hospital with acute on chronic right sided CHF exacerbation and acute on chronic hypoxic respiratory failure. The patient was diuresed as he had significant lower extremity edema. He had an ECHO that showed severe aortic stenosis. He was also found during eating and drinking to be coughing and choking. SLP was consulted and recommended a dysphagia diet. His renal function also continued to decline during his hospital stay. Given his multiple chronic medical conditions as well as the need for a chronic dysphagia diet to prevent aspiration pneumonia, the patient stated that he would rather live a shorter life with risk of aspiration than have to have his diet restricted. The patient had untreatable cancer, worsening renal dysfunction, severe aortic stenosis, as well as worsening right sided heart failure and pulmonary hypertension. After much discussion with the patient and family, the decision was made to consult hospice. Hospice consulted and there were plans for discharge from the hospital to a long term care facility with outpatient hospice services. Unfortunately when patient had a screening COVID-19 test prior to discharge, it was incidentally positive so this delayed the patient's discharge. The patient had no symptoms of COVID-19, so this was likely an asymptomatic or prior infection. Patient continued to aspirate with meals and liquids. He became progressively more hypoxic during his hospital stay and was becoming increasingly more uncomfortable. Patient was treated for his pain and shortness of breath with oral morphine with good improvement. On the morning of 7/28, the patient became very lethargic and his O2 dropped into the low 70's despite nasal cannula. The decision was made at that time to support the patient and withdrawal care in the hospital. Patient was provided medications for comfort, Oxygen was removed and the patient died peacefully on 7/28, family was present at the bedside.
Initial unsolicited report received from nurse on 12-SEP-2016. This case involves a female patient (age was not reported) who was vaccinated with a dose of ADACEL (batch number, expiry date, route and site of administration was not reported) on an unspecified day. Medical history and concomitant medications were not reported. On an unspecified day, after vaccination, the patient experienced Swelling, Pain and Rash. Laboratory investigations and corrective treatments were not reported. Outcome of the events was not reported. Documents held by sender: none.
Pt states shot given in shoulder instead of muscle and has had pain and limited range of motion since. States dull ache all the time and hurts worse upon movement.
Right arm was hot to the touch,  red and swollen 3 to 4 inches above and below where shot was given. Arm, shoulder, back and neck pain for hours and chills.
I started feeling achy on the 24th. I had a low grade fever at around 99.1 and a sore throat. I had lymph node enlargement with a bad cough as well. I completed a home test which was negative. I completed a COVID 19 PCR test at the doctors office and it was positive. I was prescribed both PAXLOVID and azithromycin. It took about 4 days before I started feeling better at all. It took a long time for them to get better. I think I had a rebound case 1 week later. I was prescribed methylprednisolone and TESSALON PERLES for my symptoms. My symptoms improved in about 5 days. I still cough every day but it's not as bad.
Morning after vaccine was given- pt developed severe edema to LUE,redness, itching,and warm to touch.
cerepal palsy; autism; This is a spontaneous report from a contactable other healthcare professional (mother) reporting for her child. A 16-year-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient took Flu vaccine eight years ago, eyes glued shut and was hospitalized, reported sticky. She does not know the ingredients but mentioned preservatives. The patient concomitant medications were not reported. On an unspecified date, the reporter stated that her child had cerebral palsy and autism and was looking for information on adverse events. Outcome was unknown for the events.   Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events cerebral palsy and autism and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
went unconscious for about 15 minutes. called 911, by the time the ambulance got there she was responsive. went to hospital to get checked.
She got her vaccine and had no reactions at all.  On 3/12/21 she was in her car and started having stabbing pain in the left side of her chest under the rib.  She thought it was gas pains and dismissed it, and then it started radiating towards the front and the stomach.  On 3/16/21 she went to the ER and they did a CT scan that showed that she had a blood clot on her spleen.  With that they gave her the diagnosis of idiopathic splenic infarction.  She was then sent by ambulance to another hospital to be admitted in case she was needing surgery.  She was given heparin and on that for 2 1/2 days.  They determined that 60% of her spleen is dead, blood supply cut off to it, and the other 40% is nonfunctional.  On 3/19/21 they gave her vaccines of Prevnar 13, HIB, meningococcal, meningococcal B, and a flu vaccine.  She was discharged on the 3/20/21 with Plavix.  She saw her regular doctor yesterday and he diagnosed her with functional asplenia and to continue the Plavix.   She is no longer having any symptoms after dissolving the blood clot.
Muscle pain all over the body; Fell sleep on the chair /  Fell forward /Falling; Sleepy; Sore shoulder; Sore Arm Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm Injection Site), FALL (Fell sleep on the chair /  Fell forward /Falling), SOMNOLENCE (Sleepy), ARTHRALGIA (Sore shoulder) and MYALGIA (Muscle pain all over the body) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Emphysema. Concomitant products included PREDNISONE for Emphysema.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm Injection Site). On 04-Mar-2021, the patient experienced FALL (Fell sleep on the chair /  Fell forward /Falling), SOMNOLENCE (Sleepy) and ARTHRALGIA (Sore shoulder). On 04-Mar-2021 at 12:04 AM, the patient experienced MYALGIA (Muscle pain all over the body). On 06-Mar-2021, PAIN IN EXTREMITY (Sore Arm Injection Site), FALL (Fell sleep on the chair /  Fell forward /Falling) and SOMNOLENCE (Sleepy) had resolved. At the time of the report, ARTHRALGIA (Sore shoulder) and MYALGIA (Muscle pain all over the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Vial punctured at 9:04am; dose given to pt at 3:28pm (24 minutes past the 6 hour expiration point). Pt did not have any adverse effects
Extremely enlarged lymph nodes along axillary and clavicle. Elevated CBC counts. Appeared 8 days post injection. Remaining enlarged still a week later. Fatigue as well.
Received Booster dose instead of full 3rd dose as immunocompromised patient; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Received Booster dose instead of full 3rd dose as immunocompromised patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    In August 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced UNDERDOSE (Received Booster dose instead of full 3rd dose as immunocompromised patient). In August 2021, UNDERDOSE (Received Booster dose instead of full 3rd dose as immunocompromised patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was back on 04 February 2021 and would like to get a full dose of Moderna COVID 19 Vaccine as the patient was immunocompromised and took a booster dose earlier instead of a third full dose. No concomitant medications were reported.  Treatment information was not provided.
Mother calls clinic at 12:50pm 3/25/10 to report patient had large red reaction around the site of injection to the extent of covering the back upper arm the day following the injection. Redness also accompanied by a lump felt under the skin around injection site. By Wednesday 3/24, there became pain and a lump on the "inside, front of her left upper arm". Redness has resolved since Tuesday, but both arms are painful to touch.
asthma; Then she attended a wedding, and she picked up COVID. Her COVID test came positive; This spontaneous case was reported by a patient and describes the occurrence of ASTHMA (asthma) and COVID-19 (Then she attended a wedding, and she picked up COVID. Her COVID test came positive) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On 08-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient received dose of INFLUENZA VACCINE (unknown route) at an unspecified dose. On an unknown date, the patient experienced ASTHMA (asthma) and COVID-19 (Then she attended a wedding, and she picked up COVID. Her COVID test came positive). The patient was treated with CIPROFLOXACINE [CIPROFLOXACIN] at an unspecified dose and frequency. At the time of the report, ASTHMA (asthma) was resolving and COVID-19 (Then she attended a wedding, and she picked up COVID. Her COVID test came positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient had her first Moderna vaccine in Feb, then Mar and May. The new vaccine she believes is called Spikevax. She was going to take the Spikevax. She already took her flu vaccine. She did have fever, sore throat, cough, and asthma. She started taking Cipro and felt better. Then she attended a wedding, and she picked up COVID. Her COVID test came positive.
Awoke 9/18/12 in AM with very painful, swollen, painful to touch (L) deltoid. Exam on 9/19/12 showed localized erythema induration & tenderness to 2 1/2 inches. Diagnosed as sterile abscess vaccine reaction. Treated with AUGMENTIN BID x 7 days.
arm is sore; bad headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is sore) and HEADACHE (bad headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced PAIN IN EXTREMITY (arm is sore) and HEADACHE (bad headache). At the time of the report, PAIN IN EXTREMITY (arm is sore) and HEADACHE (bad headache) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported.
Patient said his throat felt "scratchy" a couple of minutes after administration of vaccine. He drank some water and he received 25mg Benadryl. He refused to stay for further observation after 13 minutes from administration and he and his wife decided to leave. He danced a few steps to prove he was fine and left. I called him today and he said he's perfectly fine and that he was very nervous of needles. NOTE: Patient never showed visible symptoms of an anaphylactic reaction.
Possible febrile seizure on 7/26/06 @ 10am versus blank staring spell vs. post-ictal state. Self resolved in ~2 minutes. Has had history of febrile seizure back in January 06.8/24/06 Received medical records from PCP which reveal patient seen in ER January, 2006 for febrile seizure & diarrhea.  In March, 2006 also seen in ER for head injury s/p fall from stroller hitting back of head & becoming very sleepy. CT of brain WNL but 2 inch diameter lump noted on exam on right side of head.  Also with runny nose & cough at that time.  Dx: cephalohematoma and otitis media.  Notes also indicate frequent bouts of otitis media & was referred to ENT.  ER notes of 7/26/06 indicate URI w/fever for 2 days with seizure & vomiting on day of exam.  Admitted for overnight observation with no further seizure activity noted & was d/c following day w/dx: probable febrile seizure & viral syndrome.
Extensive swelling reaction in left arm after 5th dose of DTaP vaccine. Two days post vaccination swelling = 75x50 mm and redness = 80x80mm. No change in mid-arm circumference.
Pt had MMR vaccine for school on 5/7/01. On 5/16/01, presented to office with macular papular and itchy rash of chest and abdomen.
Strong discomfort in left shoulder immediately following injection. Shoulder continues to cause pain in certain positions due to diagnosed impingement.
While administering the dose it was noted that the vaccine had leaked out of the syringe and down the patient's arm.  It was determined that more than half of  the dose had leaked out and per the orders of RN the dose was repeated in the opposite arm.  The patient was instructed to self monitor for any adverse effects and to have someone take her to the hospital if she had any symptoms of an allergic reaction.
12/18/09 pt noticed "rash" described as red, sandpaper -like over upper half of abdomen - denies itching; pt is out of state now so unable to examine. Not yet recovered.
Information has been received from a consumer concerning her daughter who was vaccinated with a second dose of GARDASIL. Subsequently, the patient developed a knot at the injection site. No medical attention was sought. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information is not expected.
This spontaneous report as received from a certified medical assistant refers to a multiple unspecified patients of unknown demographics. On 23-SEP-2016, the patients were vaccinated with am improperly stored doses of GARDASIL 9 lot # M009378 and expiration date: 23-APR-2018, (strength, dosage and route unspecified). The vaccine was exposed to temperature of 34.6F for the timeframe of 7 hours. The call was because of a data logger. No previous temperature excursion involved. No adverse effect reported. No product quality complaint involved. No further details provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had Moderna Covid vaccine 3/3/21 and 3/31/21. Since then she had an ectopic pregnancy 10/6/21.