chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient up to date on Pfizer COVID vaccinations who admitted to the hospital with COVID complications.  Provider d/c note below:    "Brief Summary of Hospital Stay:  Per HPI, a 85 YO male that presented to the ED with c/o shortness of breath. Chronic health conditions include interstitial lung disease, PAF no AC, HFpEF, PVD, T2dm, HLD, rectal cancer history with colostomy, and hypertension.  Patient reports for approximately 4-5 days he has had worsening shortness of breath over his chronic breathing problems in which he is supposed to wear 2 L of oxygen at night when sleeping to treat.  Additionally he reports that he has had a worsening cough with this difficulty in breathing but he was not sure that it was a problem because he has a chronic cough.  He has had a loss of appetite as well.  Today he noticed that he began in feel weak and he had a fall at home outside in the yd for which he denies dizziness or injury of any kind including hitting his head or loss of consciousness.  The patient notices blood sugars were high today running around 280 so he called his PCP who instructed him to go to the emergency department.  The patient called 911 and when they showed up his oxygen levels were approximately 85%.  He reports that his daughter has been recently diagnosed with COVID and that he is vaccinated with all 3 vaccines.  He denies fever, chest pain, nausea and vomiting. He is unsure if he has diarrhea because he has a colostomy.    In the ED, hypoxic with pulse ox 77% on room air - 92% on 5 L nasal cannula, heart rate 137 lactate 2.7, procalcitonin 0.15, troponin 29 > 26 HGB 12.8, glucose 207, sodium 131, COVID positive, CXR shows bilateral infiltrates.  Received Decadron 10 mg and 1 L IV fluid in the emergency department.    Hospital Course:  Acute on Chronic Hypoxic Respiratory Failure -2/2 covid pna/ARDS in setting of underlying interstitial lung disease. Pt was started on remdesivir, dexamethasone, empiric abx with slow improvement, though pt able to wean down to 4L O2 via NC. Pulmonology recommends slow taper of steroids over 6 weeks. "  Of note - patient died on hospice services on 02/10/2022.
administered some vaccine that were expired a week ago. It was kept in the fridge.; patients were administered an "expired" vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were administered an "expired" vaccine) and PRODUCT STORAGE ERROR (administered some vaccine that were expired a week ago. It was kept in the fridge.) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A.) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were administered an "expired" vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered some vaccine that were expired a week ago. It was kept in the fridge.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were administered an "expired" vaccine) and PRODUCT STORAGE ERROR (administered some vaccine that were expired a week ago. It was kept in the fridge.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. It was reported that seven patients were administered an expired vaccine. Vials were stored in the refrigerator on 28-Feb-2022 and were all administered on 18-Apr-2022. The vial did not undergo any temperature excursions. No treatment medications were reported.   This case was linked to MOD-2022-543471-KC, MOD-2022-543474-CH, MOD-2022-543476-LH, MOD-2022-543479-DF, MOD-2022-543481-RK, (Patient Link).
out of work for 2 solid days flat on her back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: BEDRIDDEN (non-serious), outcome "unknown", described as "out of work for 2 solid days flat on her back".  Additional Information: The patient was not getting the vaccine the second time either, she was out of work for 2 solid days flat on her back.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative: Pt experienced headache, nausea, and body ache s/p COVID-19 (pfizer) booster vaccination on 3/9/2022. Per MD evaluation on3/10/2022, "Patient seen as was having nausea, feeling ill after vaccine yesterday. No reactions from prior vaccinations. Feeling much better today, participating in therapies, no dizziness, chest pain, SOB, nausea. Exam stable, at baseline." Patient ordered acetaminiphen 650mg po q4h prn headache and requested 1 dose on 3/12/2022.
3-17-08- no problem- in for well child exam. 3-18-08-Left thigh warm and red- iced increased redness, increased size. 3-19-08- Left thigh decreased redness, increase size, decreased warmth. 16 x 11 cm erythemic, warm, no tenderness 5x3 cm area within large reaction which is more firm. -no treatment, supportive care monitor signs/symptoms
Received this poison and had side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Received this poison and had side effects) in a 28-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Received this poison and had side effects). At the time of the report, VACCINATION COMPLICATION (Received this poison and had side effects) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported. No treatment medications was reported.
Info has been received from a physician concerning a 9 year old Hispanic female with no allergies or medical conditions who on 2/21/97 was vaccinated, SC, with a 1st dose of 0.5ml dose of varicella virus vaccine live. There was no illness at the time of vaccination. On approximately 9/21/05, 1 week ago, the pt experienced breakthrough chickenpox with approximately 50 lesions. Unspecified medical attention was sought. No product quality complaint was involved. No additional info was provided. Follow-up info indicated that the pt did not experience an adverse event. It was noted that on 10/22/05, the pt experienced a case of vaccine failure, developed acute varicella "attenuated" with definite papulomacules, but without vesicles. She had significant pruritus and recovered on 11/2/05. Additional info is not expected.
During normal activity around 3pm 3/9/21, patient was overcome with nausea, vomited, and required assistance to his car and home. His symptoms persisted throughout the night into the next day (3/10/21), and he went to his primary care physician. He vomited multiple times in transport and at the physician's office. Due to the nature of his symptoms and his concurrent hypertension there was concern for stroke and he was taken to the emergency department at Medical Center for evaluation around 4pm. Stroke was ruled out, and he was sent home with a prescription for meclizine with a presumed diagnosis of vestibular neuritis. 3/11/21 patient did not leave the bed except to use the restroom, however vomiting controlled with meclizine. 3/12/21 symptoms persist and patient has not yet improved.
had the first (1/24/2020) and second (2/5/2021) dose; received a third dose of Shingrix today/ had the first (1/24/2020) / second (2/5/2021) dose; This case was reported by a pharmacist and described the occurrence of extra dose administered in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 3K743, expiry date 7th October 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 24th January 2020).   On 7th June 2021, the patient received the 3rd dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 7th June 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the extra dose administered and drug dose administration interval too long were unknown.  Additional details were provided as follows: The age at vaccination was reported. Pharmacist reported that she had a patient that came in today for what was supposed to be the 2nd dose of Shingrix.  The patient called about an hour later stating that she had received 2 doses 1st on 24th January 2020 and 2nd on 5th February 2021 already, making the dose administered today the 3rd dose, which led to extra dose administered and drug dose administration interval too long. No vaccine information for the first 2 doses as they were administered at another pharmacy/facility.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021122682:same reporter - same patient - FU
PAIN AT INJECTION SITE; JOINT PAIN  IN WRISTS AND FINGERS; MUSCLE ACHE; CARDIAC ARRHYTHMIAS; BONE ACHE; LOT OF STIFFNESS; LOT OF BACK PAIN LIKE A VERY SENSITIVE, LOT OF PAIN; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included atrial fibrillation, and operation, and concurrent conditions included cardiac arrhythmias. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced lot of stiffness, lot of back pain like a very sensitive, lot of pain. On 17-MAR-2021, the patient experienced cardiac arrhythmias, bone ache, joint pain in wrists and fingers, muscle ache. On 22-MAR-2021, the subject experienced pain at injection site. The patient stated that he had pain at the injection site, muscle and bone ache, and joint ache after receiving the vaccine. He also stated that he had some cardiac arrhythmias after 1 hour of the vaccine. He had a history of A-Fib, had operation, and took medications for it. The patient stated regarding cardiac arrhythmia had not sure if the vaccine caused it "  it went away. Had them just periodically over 3-4 days. He got arrhythmias every now and then, it seems to had gotten worse after vaccine. He also stated had lot of back pain like a very sensitive, lot of pain, lot of stiffness like sometimes when he got a flu back pain, intense back pain, also joint pain in wrists and finger. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bone ache, joint pain in wrists and fingers, and muscle ache on 22-MAR-2021, and was recovering from cardiac arrhythmias, pain at injection site, lot of stiffness, and lot of back pain like a very sensitive, lot of pain. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210350444-COVID-19 VACCINE AD26.COV2.s-Cardiac arrhythmia. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
sick; Initial information received on 11-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced sick (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick (illness) (next day) following the administration of INFLUENZA VACCINE.  It was also reported that a week will never get another flu shot.  Details of laboratory data not reported.    It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown for illness.  There will be no information available on the batch number for this case.
SHINGLES ON RIGHT SIDE RIBS; This spontaneous report received from a patient concerned a female of unspecified age. 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 not reported, batch number: 201A21A, and batch number: 201A21A/201A2117 expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced shingles on right side ribs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles on right side ribs was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX. On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 9th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. In April 2018, the patient experienced muscle pain, shivering, injection limb mobility decreased, fever and tremor. On an unknown date, the outcome of the injection site pain, muscle pain, injected limb mobility decreased and fever were not recovered/not resolved and the outcome of the shivering was recovering/resolving and the outcome of the tremor was unknown. The reporter considered the injection site pain, muscle pain, shivering, injected limb mobility decreased and fever to be related to SHINGRIX. It was unknown if the reporter considered the tremor to be related to SHINGRIX. Additional information was reported as follows: At 9:30, the patient received SHINGRIX in left arm. All symptoms started together at 3:00 am morning. The muscle aches are described as severe and occurring from head to toes. One hour prior to the call to GlaxoSmithKline, the fever was 101.2 degrees. She had been unable to use the left arm to grasp a glass and drink or to raise the left arm. Just moving her fingers when she tried to grasp something made her upper arm hurt worse. The injection site pain is in her left upper arm where the vaccine was administered. On the same day of vaccination she applied cold to the arm and on the next day of vaccination heat but it was still hurting. At first she could not stop shaking but she had taken a few naps on the day of reporting, and the shivering was described now as subsiding. The patient was calling GlaxoSmithKline on the day of reporting to inquire how long these symptoms might be expected to last and was referred to her healthcare professional during the call to further discuss her inquiry of next best steps regarding her current symptoms in light of her upcoming colonoscopy scheduled for this Friday 13th April 2018. She could not take aspirin, ibuprofen for fever and aches as she had colonoscopy scheduled. The reporter was asking how long clinical trials shown these symptoms to last.
At approximately 9AM on 08/20/2003, client woke up feeling groggy with sore throat.  By noon that day client felt weak with headache muscle aches, exhaustion, sore throat, chest congestion.  PHN took Tympanic temperature on 08/21/2003 and read 99F.  Client had been taking Vitamin C for symptoms.  PHN advised fever reducer, up in liquids and if not feeling better on 08/22 to see MD as client to flying on 08/23 for college.
Client received Td vaccine 05/22/2002. LD IM. That afternoon, client had a reddened, warm area. 3- 4 inches in diameter. Left deltoid 1/2 inch above elbow in left arm. Client c/o reddened and induration. Client called health department 05/29/2002. Client states report Sx. Swelling had gone down and doing well.
Loss of taste. Took covid test to rule out having covered r. Taste is better but still a lot less than normal
Patient attended the Covid clinic and requested a Moderna vaccine. The majority of the patients were receiving Pfizer. In order to prevent the wrong vaccine from being administered the consent form was marked in big letters Moderna. I assumed the paperwork had been checked, asked patient about allergies and previous reactions and she noted no reactions or side effects. I gave the injection and when recording the date on her Vaccine card it was noted that her last vaccine booster was administered on 2/1/22.  No adverse events have been noted.
1. Dizziness/Vertigo, mild feeling of nausea.  I have had dizziness which started a few days after getting the vaccine and has continued to this day.  2. I developed what I thought was diverticulitis, with lower abdominal pain. I went on a soft diet for several days and the pain lessened. I was extremely fatigued and slept a great deal. I felt better just prior to having the second shot. After the second shot, vertigo continued and the lower abdominal discomfort, extreme fatigue started up again.  I still have the symptoms. I do not know if any of this is related to the vaccine. I only know these symptoms appeared and continue to this day. If they do not subside soon, I plan to go to the doctor. I thought I should report these symptoms.
Body ache; skin rash around my neck and underneath my arm pits and was treated for one month; Fever; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Body ache), RASH (skin rash around my neck and underneath my arm pits and was treated for one month), PYREXIA (Fever) and HEADACHE (headache) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) from 06-Jan-2019 to an unknown date and LISINOPRIL from 06-Jan-2019 to an unknown date for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced PAIN (Body ache), RASH (skin rash around my neck and underneath my arm pits and was treated for one month), PYREXIA (Fever) and HEADACHE (headache). On 16-Feb-2021, PAIN (Body ache), PYREXIA (Fever) and HEADACHE (headache) had resolved. On 17-Mar-2021, RASH (skin rash around my neck and underneath my arm pits and was treated for one month) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Body temperature: 101 (High) The patient body temperature was 101..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient went to dermatologist for rash and treated with steroid cream from 17 Feb 2021 to 17 Mar 2021. And rash was remained for 1 month.  No further treatment information was reported.
THE PATIENT HAD ALREADY RECEIVED THEIR FLU VACCINE 2 WEEKS  PRIOR TO THIS DOSE. THE DOSE WAS GIVEN IN ERROR INSTEAD OF A PFIZER BIVALENT BOOSTER. NO ADVERSE REACTION REPORTED AT THIS TIME.
Intial Covid Injection given 02012021. Leg pain and paresthesia reported to physician Feb 26, 2021, with worsening symptoms and spread through bilateral legs.  After many tests doctor of Neurology referred to other for a biopsy . Biopsy was performed 07/2022 with specimen sent to Pathology   revealing small fiber neuropathy, Pain has worsened to point of 8-10 level most days. Gabapentin dose not at 900 mg day not touching pain.
Client presented to Covid Vaccination Site for a first dose on Pfizer COVID infant vaccine, accompanied by his mother. At approximately 1630 client was held in mother?s lap ready for vaccination. When the needle was introduced into the injection site (right deltoid) by nurse, the client suddenly moved causing withdrawal of the needle from injection site. Per nurse the client was properly stabilized by the mother but client was able to move when needle was introduced to site. Per nurse  there was no vaccine pushed out of syringe. To ensure that no vaccine had been administered to the client, the dosage of the syringe was verified by both nurse and lead nurse. The vaccine was still filled with 0.2ml of Pfizer COVID infant vaccine. The syringe and the used needle were disposed of to the appropriate sharps container. The vaccine was wasted and recorded appropriately. The injection site was assessed by both nurse  and lead nurse. There was no bruising and/or redness observed. A drop of blood was observed from injection site. Lead nurse educated client?s parents that the syringe remained with 0.2ml of COVID vaccine and that a second nurse had also checked dosage in syringe.  Lead nurse also educated parents that there was no visible bruising, redness, scratches on injection site. Parents verbalized understanding.  At approximately 1634 client was administered Pfizer COVID infant vaccine Lot#FX5095 first dose by nurse in right arm an inch apart from first attempt. Client and client?s parents proceeded to the observation for a 15-minute observation before departure.  Lead nurse educated client?s parents about the possible side effects of the vaccine and when to seek medical care. An fact sheet for Pfizer Infant in Unknown version was also provided to the client?s parents. Parents verbalized understanding. Client remained in the observation area for the 15 minutes and no signs and symptoms were reported. Client left the facility with a steady gait accompanied by parents.  Lead nurse educated nurse on ways to prevent the same type of incident from happening again and was encouraged to educate parents on the need for and importance of proper stabilization of children. Nurse  verbalized understanding. At approximately 1740 a medical consult was done via text message to doctor to notify of incident and to advise if any further action is needed, doctor replied with, ?No sounds good.?
Patient awoke the following morning after the vaccine with swelling, soreness, and a warm rash. Patient stated that following day his symptoms started to improve and are improving.
Respiratory arrest ( ALTE - apparent life threatening event ) during feeding. Required CPR - In ER saturation in the 50's required c-Pap. Hospitalized in NICU 10/24/09-11/3/09.