chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse via a company representative refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies were not reported. In approximately August 2014, reported as "last week", the patient was vaccinated with PNEUMOVAX23 (dose, route and lot number were not provided). Concomitant medication was not reported. In approximately August 2014, after PNEUMOVAX23 administration, the patient experienced larger than expected swelling (a baseball size swelling) at the injection site. The outcome of larger than expected swelling (a baseball size swelling) at the injection site was unknown. Causality was not reported. This is one of two reports from the same reporter (MARRS# 1408USA011386). Additional information is not expected because the reporter refused further follow up.
Patient received for Moderna COVID-19 vaccine on 05/10/2021. Per provider ED note, patient presented to the ED on 05/11/2021 around 1 a.m. Per provider note, "He had his COVID vaccine today and got home had a lot of tingling and numbness and pins-and-needles feeling in his legs. He also nauseated and a very dry throat. He got up and use urinated and then started to feel very lightheaded like he might pass out so he tried to walk back to his bed but he passed out in the bathroom and thinks he bumped his head on the vanity. His wife heard him pass out and went to check on him. He says he thinks he was "out of it for a while, like 15 seconds."...Complaining of severe burning in his left arm...Denies chest pain or palpitations."     As of today, patient reports that he continues to experience intermittent shortness of breath, tachycardia, and tingling in his legs and arms. Patient also shared that since receiving the COVID vaccine, he has completed an EKG, ECHO, and Stress ECHO all of which has been "normal," per patient.
Information has been received from a registered pharmacist concerning a 68 year old female patient with no pertinent medical history, who in December 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (Lot number not reported). There was no concomitant medication. The registered pharmacist reported that in May 2011, the patient developed shingles on her face and in her eye. At the time of the report, the patient was recovering. It was unspecified if the patient sought medical attention. Additional information has been requested.
Fever; swollen lymph nodes; severe body aches; headache; fatigue; This is a spontaneous report from a contactable Nurse. A 48-years-old non-pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EM9809), intramuscular, administered in Arm Left on 03Feb2021 09:00 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. Medical history included migraine, drug hypersensitivity (Sulfa allergies). There were no concomitant medications. No other vaccine in four weeks and no Other medications in two weeks. No covid prior vaccination and No covid tested post vaccination. The patient experienced fever, swollen lymph nodes, severe body aches, headache, fatigue on 03Feb2021 18:30. Adverse events were reported as 101.5 fever, severe body aches, headache, swollen lymph nodes, fatigue for 2 days. The patient underwent lab tests and procedures which included body temperature: 101.5. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Splotchy rash on vaccination arm.  There is  tenderness now, but I had very little in the week after receiving the vaccine.
Breakthrough case admission after 3 vaccines Pfizer 3/15/21 Lot# En6207;  Pfizer 4/5/21 Lot# ER8730;  Pfizer 10/8/21 Lot# 30130BA
Pulmonary Embolism; This is a spontaneous report from a contactable consumer who reported similar events for two patients. This is the second of two reports. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and the concomitant medications were not reported.  The patient experienced pulmonary embolism on an unspecified date. The outcome was unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : PFIZER INC-2021526199 different patient, similar event and same drug
Initial information received on 22-Aug-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves a 55 years old male patient who experienced rash on palms and back of hand, ringworm and would be missing his dose, while he received vaccine TETANUS TOXOID. The patient's past medical history included Allergy to animal with allergies cat and dog dander, feathers, nuts, orange juice, rabbit dander. and Eczema, allergic rhinitis, pollen allergy, moderate persistent asthma. The patient's past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DUPIXENT; NASONEX; NIACIN; and PROAIR HFA and eye drops. It was reported that patient had an injury a deep cut of his arm and wrist not far from his artery, he went to hospital and they give him TETANUS TOXOID. On 23 Aug 2018, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. It was reported that patient was supposed to take his dose on 19 Aug 2018 however due to travel shipment delayed he will get it on 23 Aug 2018. On an unknown date the patient developed a non-serious rash on palms and back of hand (rash) and ringworm following the administration of TETANUS TOXOID. It was also a case of actual medication error due to Missed dose. (Other relevant tests included no lab data.) Final diagnosis was would be missing his dose and rash on palms and back of hand. An unknown corrective treatment was received. The patient outcome is reported as Unknown for would be missing his dose and as Unknown for rash on palms and back of hand. 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.
Initial misuse report received from a healthcare professional on 27 January 2014. The case was received on 21 March 2014 at agency. A 33 months old patient received FLUZONE 0.5 ml instead of 0.25 ml. No adverse event was reported. List of documents held by sender: none.
Red rash like a sunburn developed near injection site, about 3.5?x3? and further down near elbow.
Intense Headache approximately 36 hours after shot, continuing in various intensities to the present (Currently day 9).   Usually less in the morning until some strenuous exercise or activity occurs -- and then pulsating (similar to migraine, but not exactly).    Limited relief from Ibuprophen.    Patient has suffered some intermittent migraines in the past -- never lasting more than 12 hours, but has not had any incidence since relocating in 2020 until this event.
Patient developed redness and irritation at the site of PNEUMOVAX injection. Patient went to emergency department for evaluation and received CALADRYL, hydrocortisone cream and prednisone. Rash.
Patient had general malaise. Onsite EMS was called vitals HR 116 BP 146/92  98% O2.  Patient refused evaluation or care. Released against medical advise.
Pfizer vaccine was administered outside of facility - reported by patient- ? NO LOT NUMBER WERE SUPPLIED  COAGULOPATHY, UNSPECIFIED TYPE 3/20/2023 DIARRHEA COAGULOPATHY, UNSPECIFIED TYPE 3/20/2023 ANEMIA COAGULOPATHY, UNSPECIFIED TYPE 3/20/2023 LEUKOPENIA
Headache, Myalgia, Fever, chills, swollen knuckles left hand Narrative: Headache, chills, fever 100.2, swollen knuckles L hand , myalgia
visible redness and a round knot under the skin at the injection site.; visible redness and a round knot under the skin at the injection site.; other vaccine same date product flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Oct2021 15:30 (Batch/Lot number: unknown) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 27Oct2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: KEFLEX. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Right , Vaccine Administration Time: 14:00 PM), administration date: 01Mar2021, when the patient was 42 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Right, Vaccine Administration Time: 14:00 PM), administration date: 08Feb2021, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE NODULE (non-serious) all with onset 27Oct2021 21:00, outcome "not recovered" and all described as "visible redness and a round knot under the skin at the injection site."; PRODUCT USE ISSUE (non-serious) with onset 27Oct2021, outcome "unknown", described as "other vaccine same date product flu". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site nodule. Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior vaccination patient has not had covid. After vaccination patient has not tested covid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Dizziness/Lightheadedness-Mild, Additional Details: Patient felt dizzy after the vaccine and stayed in the clinic for 30 minutes. VSS. Patient left after dizziness went away.
Unprovoked tonic-clonic seizure. Lasted approx 3 minutes. Full recovery, no subsequent neurologic deficits noted. Has not recurred (as of the time of this report). Tmax measured at 100.5 F axillary. Emergency room visit with pediatric neurology consult 10/17/15; discharged home same day. Pediatric neurologist visit 10/29/15: no neurologic deficits noted.
54-year-old female with past medical history of hypothyroidism, vitamin D deficiency presenting to the emergency room with bilateral paresthesias of foot and hand.  Patient had received her first more Darner vaccine 3 weeks prior to presentation.  Patient was also noted to have left facial droop and loss of sensation on the anterior tongue.  Patient does report a prior history of cold sores on her mouth.  She was seen by neurologist outpatient where she underwent nerve conduction studies which showed delayed and prolonged F waves consistent with a diagnosis of Guillain Barre room.  Patient underwent a lumbar puncture which revealed markedly elevated protein with very few WBCs consistent with albumin cytologic dissociation.  Patient was started on IVIG for 5 days per neurology's recommendations.  Patient reported improvement in her paresthesias prior to discharge.  Patient was also diagnosed with having Bell's palsy and started on valacyclovir and prednisone per infectious disease consultation recommendations.  Patient underwent an MRI brain which revealed prior trauma/cortical contusion, and mild multiple nonspecific periventricular deep white matter foci of abnormal signal intensity, and no MR evidence of acute infarct.  Also underwent an MRI cervical spine which revealed multilevel cervical enthesopathy with moderate to severe right C4-C5, left C5-C6 and left C6-7 foraminal stenoses.  MRI lumbar spine also reviewed revealed moderate bilateral facet arthropathy at L4-L5 and L5-S1.  Thoracic spine MRI was unremarkable.  Patient's paresthesias improved.  Per neurology's recommendations, patient was discharged home to follow-up with neurology in 2 weeks outpatient.  Patient was also instructed to follow-up with her primary care doctor in 2 to 3 days for hospital discharge follow-up.
pt c/o itching, hives, & swollen tongue;pulse ox 96% @ 10:35;pt given DPH & Epi;pt had relief;pulse ox 98% @ 11:00;
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 28-FEB-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R019391 with expiration date 05-JUL-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
I was vaccinated on 4/18/2021 at 12:10pm. Within 6 hrs, I feel very cold, severe headache, tiredness, body aches and fever till next 48 hours. I took Tylenol and I feel much better on 3rd day morning (Wednesday). However, on Thursday, I feel throat soaring. I took Claritin and throat soreness stopped.  On Friday, I feel little gland swelling on right side neck and on Saturday the swelling is bit more prominent. While swallowing food and drinking water, I am feeling awkward in neck.
Previously had Covid 19 Nov 9, 2020.  Developed same exact symptoms that i had then.  24 hours later, developed headache, severe sore throat, fever, and aches that have continued into day 4.  Felt like I had Covid all over again
Shingles on left flank.  Treated with Acyclovir five times per day for ten days.
I had chills and muscle cramps after first shot.; I had chills and muscle cramps after first shot.; This is a spontaneous report from a contactable consumer (patient).  A 51-year-old male patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6201 and expiry date was not reported), via an unspecified route of administration, on 11Mar2021 at 11:00 AM (age at vaccination: 51 years), on left arm as a dose 1, single for COVID-19 immunization. The patients medical history includes pancreatitis. The patient concomitant medication includes Norvas, Pepcid,protonax, and multi vitamins. It was reported that the patient had no known allergies. It was reported that the patient had not received any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. It was reported that patient was tested to COVID post vaccination. On 11Mar2021 03:00 PM patient had chills and muscle cramps after first shot. Patient had not received any treatment for the events reported. outcome of events recovered on unspecified date in 2021.  Follow-up attempts are completed. No further information is expected.
In Oct90 10 out of 59 pts were found to have insuff or neg antibody levels during post serology testing for anti HBs. (see EBU910168 - EBU910176)
This spontaneous report was received from a registered nurse regarding a patient of unknown age. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 25-FEB-2019, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # R018735, expiry date: 06-APR-2020) for prophylaxis. Temperature and time frame of temperature excursion was noted as from 29-JAN-2019 (12 Degree Celsius for 1 hour 21 minutes) to 26-FEB-2019 (10 Degree Celsius for 22 minutes). It was reported that there were no previous temperature excursions. Digital data logger was noted as Yes. No adverse events were reported. The outcome of product storage error and no adverse event was unknown. This was two of nine reports mentioned in the report. Sender's Comments: US-009507513-1903USA009054.
Fever, coughing, drowsiness, generalized weakness. Was found to be hypercalcemic (corrected calcium 14) and admitted 1/2-4. No prior history of hypercalcemia.
The vial was initially stored in refrigerator was on 04-Jun-2022 and vaccine administered on 23-Jul-2022; No adverse event; Patient administered the vaccine after the 30 days by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator was on 04-Jun-2022 and vaccine administered on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 23-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator was on 04-Jun-2022 and vaccine administered on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator was on 04-Jun-2022 and vaccine administered on 23-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 days by used) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator was on 04-Jun-2022 and vaccine administered on 23-Jul-2022).    No concomitant medication was reported.  Patient received half dose of vaccine.  On 04-Jun-2022 the vials were initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  No treatment information was provided.
Rt arm after PNEUMOVAX is swollen and hot to the touch, pt complains also hurts to move arm- resolved by 10/17/17.
Moderna COVID-19 Vaccine with lot number AS1417B was administered to a patient on March 9, 2023 at 11:30am, greater than 12 hours post first vial puncture on March 8, 2023 at 11:30am. Manager contacted Moderna Medical Support on 03/10/23 @ 8:02am, in which they sent the following statement: "Moderna has data to support the stability of its vaccine if appropriately stored according to the Storage and Handling section of the Fact Sheet for Healthcare Providers and Full Prescribing Information (1). If the dose was given within the 30-day beyond use date, was NOT exposed to ambient room temperature (46° to 77°F (8° to 25°C)) for greater than 24 hours and any previous temperature excursion was analyzed a
Nausea, vomiting, and dizziness after receiving vaccine in Employee Health clinic. Employee Health gave ondansetron (details unavailable) for symptom relief.
children were prescribed antibiotics and then developed thrush; children ended up in unknown emergency rooms with high fevers; This spontaneous report was received from a registered nurse and refers to a child patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies, and drug reactions or allergies were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (strength, dose, frequency, lot #, and expiration date not reported) for prophylaxis.  On an unknown date, also reported as "after receiving measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II)", the child ended up in an unknown emergency room with high fevers (pyrexia). Subsequently, the patient was prescribed unknown antibiotics (antimicrobial (unspecified)) (strength, dose, frequency, lot #, and expiration date not reported) for an unknown indication. On an unspecified date, the patient developed thrush (candida infection). It was noted that the reporter inquired about the availability of measles virus vaccine, live (Enders-Edmonston) (ATTENUVAX) and mumps virus vaccine live (MUMPSVAX). The action taken with antibiotics (unspecified) regarding the events was not reported. The outcome of the events was unknown. No further information provided.  The causal relationship between pyrexia, candida infection and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2002USA011146: US-009507513-2002USA008445: