chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID Vaccine Breakthrough Case  Moderna Dose 1 2/9/21 (013M20A) Moderna Dose 2 3/9/21 (002A21A) COVID Positive 11/4/21  11/4/21: Patient is 72-year-old female with past medical history of Alzheimer dementia, type 2 diabetes mellitus, hypertension, dyslipidemia and obesity. to the emergency room by her daughter for complaint of diarrhea and increased confusion.  Patient has Alzheimer dementia with mild cognitive decline.  Patient was able to engage in meaningful conversation and  give history. History was corroborated by her daughter.  Patient was seen at Hospital ED on 10/27/2021 for complaint of right-sided body weakness, unsteady gait and frequent falls for a week. She had multiple workups including CT head which was negative.  Patient was sent home with an appointment follow-up with her neurologist.  She was also started with aspirin 81 mg p.o. daily. She was seen at her neurologist's office 2 days ago and was presumed to have possible stroke.  Further evaluation for stroke with MRI of the brain and CT angio head/neck was planned by her neurologist and patient was scheduled to have this test done next week.  However, since 4 days ago, patient has been having diarrhea.  Patient reported up to 3-4 loose bowel movements.  No associated abdominal pain, nausea vomiting.  No report of fever chills or rigors.  Stool was brown in color.  No associated blood.  Patient also reported increased weakness. Family members also reported increased confusion.  Since her recent diagnosis for stroke, she has been using a walker.  Family members reported less episodes of fall since she started using walker. No report of chest pain, shortness of breath or palpitations.  No urinary complaints.  Patient denied use of laxatives.  Patient is fully vaccinated for COVID-19. She denied use of tobacco products.  She drinks alcohol occasionally.  Upon evaluation at the emergency room, she was afebrile, hemodynamically stable and maintaining saturation on room air.  Significant lab findings were hypokalemia 3.3 and leukopenia 3.27.  EKG revealed sinus bradycardia without acute ST or T-wave changes.  CT head without contrast was done which showed prominent area of low-density in left parietal lobe suspicious for acute infarct.  11/8/21: Patient is 72-year-old female with history of hypertension, hyperlipidemia, recently diagnosed Alzheimer dementia, and depression who presented with right-sided weakness admitted for CVA workup found to have small multifocal subacute infarcts involving the left parietal lobe.  Started on aspirin, statin, neurology consulted. Patient was complaining of diarrhea, tested positive for COVID-19 with no respiratory involvement.  Was on supportive care with IV fluids.  Worked with physical therapy and did very well and plan to discharge to home today.
Vaccine administered May22, 2009.  LMP June 14, 2009.  Confirmed Pregnancy August 5, 2009 - 7.5 weeks gestation.
This is a spontaneous report from a Pfizer-sponsored program, by a contactable physician. A 20-year-old female patient receive the first dose of TRUMENBA, at 0.5 ml single in the right deltoid on 07Aug2016 for immunisation. The patient medical history and concomitant medications were not reported. On 07Aug2016, the patient experienced numbness and tingling in all four extremities, headache, chills, some perioral cyanosis, chest tightness. The outcome of the events was recovered on 08Aug2016.
I had severe RLQ abdominal pain, fever, nauseous and ended up having acute appendicitis. Due to spread of infection/inflammation, I underwent open ileocecectomy with primary anastomisis, IV antibiotics and hospitalized for 3 days.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 11Jan2021 as dose 2, single (Lot number: EL1283), in left arm and on 13Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NYQUIL oral, start date: 07Jun2022, stop date: 08Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative, notes: On day 5, I tested negative; positive, notes: on day 8 and 10, I tested positive (rapid test). Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are required. No further information is expected; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded
On 3/10/21 after patient received his covid vaccine booster of Pfizer he told the technician that his neck was tingly/numb.  Technician called Registered Nurse(RN) from Pharmacy then she sat him down and assessed him. RN asked him how are you feeling, describe sensation, asked if he ever had this happen to him before and reported no and described his neck was tingly to numb. RN asked to palpate the area and noted that there was no harded areas and no lymph nodes and no tenderness. RN asked if he had any dry mouth, excess saliva or trouble swallowing and he reported no. RN asked if the sensation was moving or changing at all and he reported it was moving up his neck. RN asked how old he was and if was driving himself, and he wanted us to reach anyone if we needed to. Patient reported he was not driving and he was 18. RN said If the sensation was changing, we had some Benadryl(diphenhydramine 50mg capsule) on hand. RN asked school nurse for water. Pt said he has taken Benadryl before . RN told Pt he would have to stay longer if he would take the Benadryl and then RN went to talk to school nurse.   RN placed one 50mg Banophen capsule on her hand and said this is what we have on hand incase you need it. Patient took it from RN?s hand and decided to take the Banophen capsule.   RN asked technician to message the pharmacist what to do after patient took the Banophen and if there additional paperwork needed. Technician told pharmacist that they had given Benadryl to someone and if there is any paperwork. Pharmacist told them to watch them for 20-30 minutes and did not need paperwork yet. Then pharmacist called them back in a few minutes right after since she herself was at another clinic and told them to call 911  and if they have questions to call me back. Simultaneously, Rn said she is going to talk to school nurse who reported familiarity with the patient . School nurse said she is familiar with the patient and he has had the same compliant before unrelated to the vaccine. RN reported what happened to school nurse and what she did. RN returned to room to check on patient and he reported he had this feeling in the past. Rn also asked patient to call parent to report what happened in collaboration with the school nurse.  By the time RN alerted to call 911 patient was asymptomatic after being monitored approximately 20 minutes.  RN offered to call 911 and patient refused to have the nurse call 911 so it was documented on paper that he refused help. He said he spoke to his dad and his dad told him to come home and rest. The patient was doing okay after nurse monitored him and did not have any other symptoms when they left.
I'm not sure if this is from my vaccine.  I started getting hives well over 2 months from receiving it. I went to my ER twice with severe hives the second time was given Hydroxyzine 50MG that cleared my hives up with in 2 hours. This was Sunday 5/23 night at about 3 am I stayed hive clear till Thru 5/27 at about 5 PM. Now the Hydroxyzine is no longer working.
A non-serious, spontaneous report of fever and positive flu test has been received from a physician, concerning a five-year-old female patient subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 06-Sep-2009. On 08-Sep-2009, the patient started running fever of 102. She tested positive for Flu B on 08-Sep-2009. The outcome of the events was not reported.
Admitted on 12/21/22. Transferred to Hospital on 12/28/22 for transitional care stay.
He had his Covid vaccine series, second vaccine on 4/17/21, then developed a spontaneous DVT on 5/14/21.
15 month old male brought by mother with redness and moderate swelling at the site of DTap injection in the left thigh given yesterday. There was no fever or rash and pt has been playing as if without pain. 9x9 cm area of redness and swelling without lymphangitic streaks in the anterior aspect of the left upper thigh with a 1x1 cm non-tender induration around the puncture site
This spontaneous report was received from a physician refers to 5 patients of unknown demographics. On an unknown date the patients were vaccinated with a dose of ROTATEQ (lot#, expiration date and route not reported). The physician reported the patients experienced projectile vomiting immediately after administration of the first dose of ROTATEQ. The outcome of vomiting projectile was unknown. Causality was not reported. Additional information has been requested.
Patient started having pain and sensitivity 3 hours after injection along left flank. Shingles rash erupted 1/10/2021
T106 (ax) & fever for 10 days per mom;rash over body;
64 y.o. female with significant comorbidities of essential hypertension, T2DM, moderate COPD (PFTs 2020), restrictive lung disease of obesity with OHS, chronic right-sided heart failure, VTE on rivaroxaban, and more recent history of spontaneous colonic perforation in March 2022. Presented to ED with nausea, poor appetite, generalized malaise and muscular weakness and was found to have severe hyperkalemia and AKI.  Tested positive upon admission
Patient completed 2nd dose of covid series on 2/12/21. She became symptomatic and tested positive for covid on 3/24/2021.
Headache  increasing to loss of conciuounes followed by hot and cold episodes. Lower left arm and hand turned a light yellowish (Jaundous) color. The following day 5/28/2021 more dizziness and nausa with migraine and  fatigue leading to days of falling asleep for hours at a time. Headach with presure increasing until nose bleeds lasting 2 more days. Fatigue is still on going
fussy p/supper-mom gave APAP;in AM went to babysitter notice lt leg swollen @ site of inj;taken to ER-seen by MD advised warm compress to swollen inj site;told infect secondary to inj;feels hard but not fussy now;
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe, Additional Details: Patient most likely experience vasovagal syncope
Information has been received from a registered nurse concerning a female patient who between 10/22/2004 and 10/25/2004 was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 647655/0869N).  Subsequently the patient developed redness around her arm.  Unspecified medical attention was sought.  The patient recovered.  It was also reported that 4 out of 5 patients have had injection site reactions after receiving pneumococcal 23v polysaccharide vaccine from the same vial.  The doctor questioned the vial and lot number since all doses were from the same one.  The records of testing prior to release of this lot have been checked and found to be satisfactory.  The lot complies with industry standards.  Additional information has been requested.
Approximately 12-24 hrs after receiving vaccine patient developed hrs after vaccine patient noted subjective warmth/myalgias/fatigue. Greater than 48 hrs after vaccine patient noted flushing to trunk/axilla/groin. Resolved within 48 hrs without treatment.
Blood test abnormal; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of BLOOD TEST ABNORMAL (Blood test abnormal) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No medical history was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced BLOOD TEST ABNORMAL (Blood test abnormal). At the time of the report, BLOOD TEST ABNORMAL (Blood test abnormal) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: elevated (High) inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment information was reported.   This case was linked to MOD-2021-113543 (Patient Link).
No additional adverse event; adult patient was inadvertently administered a pediatric dose; adult patient was inadvertently administered a pediatric dose; This spontaneous report was received from a nurse and refers to an adult female patient of unknown age. No information regarding patient's concurrent conditions, past medical history, concomitant medications, drug reactions or allergies was provided. On 08-JAN-2020, the patient was inadvertently vaccinated with a pediatric (instead of adult) dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) thimerosal free, injection, pediatric dose (0.5 ml), lot number R031056, expiration date 04-JUN-2021 (route of administration was not provided) for prophylaxis. On that day, the patient experienced incorrect dose administered and accidental underdose, as administered dose was pediatric. No adverse events was reported.
Pt brought by parents after having a tonic-clonic seizure at home at 5:30 in the morning after receiving his shots (given approx. 13 hours earlier). Pt also had fever of 101 degrees F. When seen in clinic four hrs later, pt had complete recovery.
Patient had an MMR vaccine and had slight erythema around it, was demarcated.  Patient was given Benadryl and ice, and over an hour's time there was no progression and actually shrinkage of the redness.
This spontaneous report was received from a nurse regarding a 6-month old patient. The patient's concurrent conditions, concomitant therapy, medical history and historical drugs were not reported. On 15-MAY-2017, the 6 month old patient was vaccinated with first dose of ROTATEQ orally, (lot # M031650, expiry date: 16-MAR-2018) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported. No product quality complaint involved.
I am reporting this AE as the patient. I think I have what people have been calling "vaccine arm." After 1 week after my injection, the injection site has become very swollen, large hard bump, and warm to touch. There is no rash. I have not treated this reaction yet (day 2 of the reaction) however plan to take Zyrtec to help with the swelling. I usually get this type of reaction after I get a bug bite but the symptoms post-vaccine injection are definitely more notable (i.e., more swollen, bigger bump) as compared to a bug bite. I also have swollen lymph nodes on the same side as the injection site (left side of my neck/shoulder).
Sore Arm, Sore Joints (knuckles of hand), Chills, Fever, Aches, Headache, Fatigue, Muscle Weakness. Worst at 12 hours 1st evening - slowly getting better over next 24 hours with rest.
not inserted into the mid portion of the deltoid muscle; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (not inserted into the mid portion of the deltoid muscle) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received 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 experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (not inserted into the mid portion of the deltoid muscle) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (not inserted into the mid portion of the deltoid muscle) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant information provided No treatment information provided
no additional AE; expired GARDASIL 9 lhat was accidently administered to a patient today; This spontaneous report was received from a nurse and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 04-NOV-2020, the patient was vaccinated with expired first of three in series dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 ml, lot # N035032 with expiration date on 24-SEP-2020 (route of administration and anatomical location was not reported) for prophylaxis. No additional adverse event was reported.
This is a spontaneous report from a contactable pharmacist reported for herself via Pfizer sales representative. This female patient (who is a pharmacist) of an unspecified age received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swelling all the way up her arm on an unspecified date with outcome of unknown. No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Very lethargic temp 103, one red spot with white head on abdomen. Varicella SE vaccination
12 hours after vaccine, fever to 101.2 with associated chills; 18 hours after vaccine, focal painless swelling of gingiva; 30 hours after vaccine, aphthous ulcer formation on lower lip; persistent fever with Tmax of 102.1 and associated moderate chills; 36 hours after vaccine, diffuse gingival inflammation with moderate-severe pain without bleeding and multiple aphthous ulcers on lower lip and buccal surfaces. Fever resolved 60 hours after vaccine.
This spontaneous reported as received from a medical assistant refers to a 12 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-MAR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # L031601, expiration date: 18-FEB-2017 (therapy type, exact dose, route of administration and anatomical location were not provided). There were no adverse events reported. This is one of several reports received from the same reporter. This is one of two reports concerning the same patient. Additional information has been requested.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Mar 25, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced pain in extremity, onset 2021, with outcome of unknown. Additional information: The patient received the 1st dose of the Pfizer COVID-19 vaccine on Mar 25, 2021; and due for the 2nd dose this Thursday (at the time of report). She mentioned she had no reactions to the vaccine except for maybe a little soreness in the arm. She asked if it would still be safe for her to accommodate a friend who got vaccinated with her 2nd dose of the Moderna vaccine. She mentioned her friend had COVID-19 three months ago, and had a reaction to her 2nd dose. Her friend plans to visits her from an area that withdrew their mask policies and allows people to go without masks; so she was really concerned about her friend's situation. Patient questioned if it is true you have to get a booster after 6 months; and if the vaccine protects against the other variants. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Pt received 1/2 dose in (L) nostril, following 1/4 dose in (R) nostril began to bleed from (R) nostril. Dr examined and could not determine site of bleed.
After my third dose of Moderna (right arm),  my rms felt like I was being bitten by a thousand fleas. I've had hives in the past and recognized it as early symptoms of hives. I immediately took 50 mg of Benadryl.  Nevertheless,  I developed five welts on my right arm and one welt on my left arm that were itchy. I took another 50 of Benadryl later that night.  The welts had subsided by then and were no longer itchy; they were still visible though not red.. This morning,  I have a fever of 101.4 but the welts are gone and I am not itching.    Previously,  I had a fever after the 2nd dose but not after the first dose.
Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore injection site arm) in an elderly female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Sore injection site arm). At the time of the report, INJECTION SITE PAIN (Sore injection site arm) had not resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient reported two adverse events in her discussion. Patient had a sore injection site arm and said that she had heard horror stories of patients who have received the primary series of the Moderna Covid-19 vaccine. Treatment information was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2023: Live Follow-up received and had no new information.
tested positive for Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid-19) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 05H21A, 016C21A and 020B21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Adhesive tape allergy.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2022, the patient experienced COVID-19 (tested positive for Covid-19). At the time of the report, COVID-19 (tested positive for Covid-19) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Oct-2022, SARS-CoV-2 test: Positive. Patient stated she took regular medications on daily basis but she have not reported the names because they are a lot. Patient did not received other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Treatment details was not reported by the reporter.