chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination Failure; COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Other HCP).  A female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown) and in Mar2021 as dose 2, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolemia" (unspecified if ongoing); "Allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 09Feb2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 09Feb2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Feb2023) Positive, notes: Nasal Swab. Clinical course: Patient started experiencing sore throat yesterday which quickly developed into muscle aches. Today, dry hacking cough started. No prior to vaccination, was the patient diagnosed with COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events DRUG INEFFECTIVE and COVID-19 and BNT162B2.,Linked Report(s) : US-PFIZER INC-202300062567 same patient, different event, different dose.;US-PFIZER INC-202300063952 same patient, different event, different dose.;
2 wk s/p vaccines, pt developed red nontender patch at injection site. 2 days later, pt had induration and tenderness and was treated with Clindamycin (pending would culture) for cellulitis.
On 2/23/08 child received MMR and Varicella vaccinations during routine one year check up. No adverse events reported to physician prior to death on 2/27/08. 6/25/2008 Postmortem examination report received. COD-Acute Febrile Illness. DX based on exam:  Pale doughy lungs. Bite marks on lower lip. Febrile illness by history. Acute inflammatory cells in walls of bronchi in peribronchial alveoli.
Information has been received from an 18 year old female consumer, who was vaccinated with two doses of GARDASIL (per dosing schedule). The first dose was received on approximately 18-JUL-2009 and the second dose on 18-SEP-2009. Consumer stated that she developed pain, swelling and bruising at the injection site moments after receiving her first and second dose. Two days after her second dose, on approximately 20-SEP-2009, she experienced swelling of her glands in the underarm and neck area, leg pain, tiredness, acid reflux, nausea and headaches. At the time of the report the consumer had not recovered. Additional information has been requested.
-Complex Regional Pain Syndrome  (May 2017) -ER Visit for Gastrointestinal Pain (October 2017) -ER Visit for Dyspnea (Nov. 2017) -Hospitalized with Viral Labial Swelling (February 2018) -Diagnosed with Epstein Barr Virus  & Elevated Mycoplasma Pneumoniae (March 2018) -Hospitalized with Chronic Pain (August 2018) -Hospitalized for Pain Rehabilitation?Management Program(September 2018) -ER Visit for Ear Pain (January 2019) -ER Visit for Head Pain (Nov. 2019) -Hospitalization for Gastrointestinal Pain (February 2020) -
This spontaneous report was received from an office manager concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 08-SEP-2016, the patient was inadvertently vaccinated with a pediatric dose of VAQTA Lot# K026529, expiration date: 02-JUN-2016, 0.5 ml by an unspecified route (accidental underdose). There were no concomitant medications and adverse effects reported. No product quality complain was involved. Additional information has been requested.
Large area of redness and swelling developed over 48 hours at the site of the immunization - measures approx 3 by 4.5 inches, warm to touch and tender with two small adjacent lesions which look like mosquito bites
Less than 5 minutes following administration patient fell lightheaded and dizzy then passed out. Her boyfriend caught her on her way to the floor. She was unconscious for less than 1 minute. Patient then laid on the floor flat on her back for 5 minutes then moved to a chair and sat in an upright position for an additional 15 minutes. Patient then felt better and left the pharmacy.
HPV (Gardasil 9) vaccine was expired at time of injection. Expiration date 4/3/2022. All expired doses removed and disposed of accordingly.
This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 21Dec2020 15:30 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced allergies. On 23Dec2020 13:00, patient discovered a lump on the bottom of her left armpit, felt a lot of discomfort when touching it. It went away around 02Jan2021. Patient does not have COVID prior vaccination. COVID was tested post vaccination via nasal swab, COVID test date on 07Jan2021, and COVID test result was negative. No treatment was received for the events. The events recovered on 02Jan2021. Information on the lot/batch number has been requested.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for two patients. This is the second of two reports. A patient of an unspecified age and gender received PREVNAR 13 via an unspecified route of administration on an unspecified date at single dose for immunisation. Relevant medical history and concomitant medications were not reported. The pharmacist reported that the patient did not want subsequent PNEUMOVAX 23 shot because their first pneumococcal shot, the year before this report, of pneumococcal 13-val conj vac (dipht crm197 protein) was too painful. At the time of the report, the outcome of the event was unknown. The information on the batch number has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018401776 same reporter, suspect drug and event, different patients.
26 Patient received a expired vaccine 16Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) in a 58-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 007J21-2a) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Apr-2022 at 1:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (26 Patient received a expired vaccine 16Apr2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
18 mon. female w/ DPT 11:00am in lt thigh. 48 hrs /p  T 101-103 w/ irritability refused to bear weight or sit up. Refusing solid food but drinking Pedolyte well.  Peak T 103, Excessive sleepiness the past 48 hrs.
Information has been received from a physician concerning a female patient who was vaccinated with a first dose of Gardasil.  The physician reported that after the first injection the patient experienced confusion and lack of concentration.  No further information provided.  The outcome was unknown.  Additional information has been requested.
muscle cramps and aches; Dizziness; overall just don't feel good.; fatigue; headaches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of MUSCLE SPASMS (muscle cramps and aches), DIZZINESS (Dizziness), FEELING ABNORMAL (overall just don't feel good.), FATIGUE (fatigue) and HEADACHE (headaches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (muscle cramps and aches), DIZZINESS (Dizziness), FEELING ABNORMAL (overall just don't feel good.), FATIGUE (fatigue) and HEADACHE (headaches). At the time of the report, MUSCLE SPASMS (muscle cramps and aches), DIZZINESS (Dizziness), FEELING ABNORMAL (overall just don't feel good.), FATIGUE (fatigue) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported. Treatment information as not reported.
Injection site red. left arm discoloration to elbow left arm inflammation, (L) supra clavicular inflammation of the lymph node. Bowel movement x 3 5/10/08. General body ache. Temp 101.0 f, chills - Flu-like symptoms.
Benign paroxysmal positional vertigo; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 30-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 29Jul2021 09:00 (Lot number: Ew0165) at the age of 30 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VERTIGO POSITIONAL (non-serious) with onset 05Aug2021 08:00, outcome "not recovered", described as "Benign paroxysmal positional vertigo". The event "benign paroxysmal positional vertigo" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vertigo positional.  Additional information: No known allergies. No other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was no. Adverse event treatment was vestibular physical therapy. No hospitalization prolonged. Serious was no. Since the vaccination, the patient had not been tested for COVID-19. Device Date: 19Aug2021.  Follow-up attempts are completed. No further information is expected.
Red spot at injection site with little red (2-3 inch around) bumps around it, itching.
Pain at injection site; Extreme fatigue; This is a spontaneous report from a contactable consumer (Daughter in law). A 79-years-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Formulation: Solution for injection, Batch/lot number and  expiry date: unknown), via an unknown route of administration (location of administration was unknown) on an unspecified date in 2021 as single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced pain at injection site and extreme fatigue. The patient taking COVID vaccine last night. She primarily experienced pain at injection site and extreme fatigue. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Received FLUMIST 10/31/11 at school. Developed fevers & on night 11/2/11 - 11/3/11 had bilateral leg pain unable to walk. Went to ER 11/3/11 & to peds clinic 11/3/11 later that day. Labs showing rhabdomyolysis.
site on injection: right arm red, swollen , and tender to touch  vaccines  given on 2/9/23 around 2:30  mother called doctor office on 2/11/23 for symptoms around 9:00 a.m.  mother noticed symptoms on 2/10/23 patient also received Tdap and Hep B but was given in left arm.
pt recv vax JAN98 & pt exp a local rxn that was very red & swollen;there was no resp distress;
Vertigo, sporadic throughout the day.  Now only for a moment when I get into or out of bed.
Information has been received from a 71 year old female with aortic aneurysm, a history of pancreatitis and history of drug reactions or allergies who "two weeks ago" (no approximately 05-AUG-2008) was ZOSTAVAX (Oka/Merck) 0.65ml IM. Concomitant therapy included pravastatin, lisinopril (manufacturer unknown), metoprolol, levothyroxine, pantoprazole and CHANTIX. "Within the last 2 weeks" (on approximately 05-AUG-2008) the patient developed muscle pain in her neck, shoulder and legs after receiving ZOSTAVAX (Oka/Merck). The patient's muscle pain persisted. Liver function tests were performed (results not reported). The patient didn't seek medical attention. Additional information has been requested.
Child was accidently given the whole undiluted vial of Covid Pfizer vaccine age 6 mos to 4 years
One week of high fever, temperature over 104 with cough, congestion, bilateral otitis media, irritability, decreased sleep, decreased appetite, and lethargy.  Four office visits.
Heart Flutters with second dose.  Went to doctor.  They did not tell her not to get the booster dose.
Pt received 2nd Bivalent booster by request. Staff unaware this was a 2nd bivalent booster. Pt had no side effects.
Sore at injection and started to feel warm. As day went on arm ached and got hotter and hard and red.  Didn't sleep well that night and next am called pharmacy back.  Suggested Benadryl and Tylenol.
A 77 year old female who presents with patient states went to see PCP today for six-month labs and was noted to have elevated BP.  Patient's has never been diagnosed with hypertension.  She states after going home she got a headache and dizzy since she recheck her blood pressure and noted that it was 190/106.  Patient denies any chest pain or shortness of breath and says that her headache is resolved.  2039 BP 145/78, PT FEELS FINE.  EXPLAINED TO PT WILL CHECK A SECOND TROPONIN WITH ABNORMAL EKG AND ELEVATED BP. PT VERBALIZED UNDERSTANDING. SECOND TROPONIN NEGATIVE WILL START PT ON ATENOLOL 25 MG DAILY AND DISCHARGE TO FOLLOW UP WITH PCP.
Large red area on left arm around where shot was given.  Very hot and itchy.  Under arm area hurts when putting on deodorant (the pressure is what causes pain)  It started a week after shot was given.  Using itch spray and ice packs.  Slowly feeling better but still having issues 3 days later.
Patient is a very pleasant 85-year-old male who presented to the emergency department first on 3/8/2021 via private vehicle accompanied by his spouse in no acute distress with complaints of left arm pain and swelling after receiving his Pfizer COVID vaccination on 3/2/2021.  Medical history includes hypertension, heart failure, CAD, GERD, diaphragmatic hernia, chronic left shoulder pain, among others. Patient states he received his vaccine on Tuesday and began to develop pain, swelling, and bruising at the injection site on Thursday. Since that time all of his symptoms have worsened. 9/10 pain this morning has lowered to a 4/10 after 2 tylenol, which he took approximately one hour prior to arrival. Is not anticoagulated but takes baby aspirin daily. He did stop this when he first noticed the bruising. Denies recent trauma, including falls. His chronic left shoulder pain is unchanged from baseline; the pain he presents to the ED for is located lower at the injection site. Further notes pain patches helpful with his pain.  Seen again on 3/15/2021 for persistence and involvement of his forearm with the bruising and pain.Over the last week the purple discoloration has migrated down his arm towards his hand.  He denies any new numbness or weakness in the arm. Exam reveals impressive and extensive ecchymosis that involves both his upper and lower arm and is circumferential in nature.  There is no area of discrete swelling or tenderness.  Good peripheral pulses and capillary refill.  Normal strength of hand.  An ultrasound done showed no clot.
This case was reported by a other health professional via call center representative and described the occurrence of contusion in a female patient who received FLUARIX QUADRIVALENT for prophylaxis. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced contusion and wrong technique in product usage process. On an unknown date, the outcome of the contusion and wrong technique in product usage process were unknown. It was unknown if the reporter considered the contusion to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a large bruise. The air was not expelled from the syringe prior to administration, which led to wrong technique in product usage process. The patient had denied permission to contact their physician. The reason for the call was to ask if the air needed to be expelled from the prefilled syringes prior to administration. The healthcare professional stated that their health system nurse was in providing vaccination and did not remove the air and one of the recipients did develop a bruise. The healthcare professional was not sure if it had anything to do with the air or not. The healthcare professional did not have any product or patient info, as it was not their stock given.
This spontaneous prospective pregnancy report was received from a registered nurse, and refers to a currently 26 year old female patient. The patient's concurrent conditions included asthma and nausea. Concomitant therapies included metoclopramide hydrochloride(REGLAN), mometasone furoate (+) formoterol fumarate(DULERA) and levalbuterol hydrochloride(XOPENEX). She had no drug reactions or allergies. On 10-MAY-2017, the patient was vaccinated with the first dose of GARDASIL 9 0.5 ml, per intramuscular route, for Human Papillomavirus prevention (lot number N017833, expiration date 16-NOV-2019). On 12-JUL-2017, she was vaccinated with the second dose of GARDASIL 9. On 09-NOV-2017, the patient was vaccinated with the third dose of GARDASIL 9 at which time pregnancy test was negative. The patient did not have her menstrual cycle in December 2017. On 29-JAN-2018 it was determined that patient was pregnant with twins, gestation 8 weeks and 3 days. Last menstrual period was on 06-NOV-2017. Estimated date of delivery was 13-AUG-2018. No adverse effects were reported.
Persistent screaming for 2.5 hrs p/immun w/3rd DTP/HIB vax;
Since the vaccine patient had come down with cancer and SVT; Since the vaccine patient had come down with cancer and SVT; This spontaneous case was reported by a patient and describes the occurrence of NEOPLASM MALIGNANT (Since the vaccine patient had come down with cancer and SVT) in an 84-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     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 NEOPLASM MALIGNANT (Since the vaccine patient had come down with cancer and SVT) (seriousness criterion medically significant) and SUPRAVENTRICULAR TACHYCARDIA (Since the vaccine patient had come down with cancer and SVT). At the time of the report, NEOPLASM MALIGNANT (Since the vaccine patient had come down with cancer and SVT) and SUPRAVENTRICULAR TACHYCARDIA (Since the vaccine patient had come down with cancer and SVT) outcome was unknown.        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.   No concomitant medications were reported.  No treatment information was provided.  Company comment-This spontaneous case concerns an elderly female patient aged 84 years with no medical history reported, who experienced the unexpected serious (medically significant) event of Neoplasm malignant and unexpected non-serious AESI event of Supraventricular tachycardia that occurred in the context of mRNA-1273.222 vaccination in covid -19 vaccination series. Latency cannot be assessed since onset date of events and date of vaccination was not disclosed. It was reported that since the vaccine patient had come down with cancer and SVT. No further information on risk factors, concurrent illness, detailed clinical course, investigations, treatment of the events, outcome of the events and details pertaining to the previous doses was available in the report. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-714580 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-714580:Master case
Non pruritic, maculopapular lesion to upper extremities. Two lesions above belt line to back.
Inappropriate age at vaccine administration; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 14-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment drug information provided. No concomitant drug information provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: follow-up received on 06-AUG-2021 contain No new information was provided. On 10-Aug-2021: follow-up received on 10-AUG-2021 contain No new information was provided.
Erythema R arm 5-8 cm non recede ha 2x4 cm area of raised induration.
Presented to outside hospital ED with complaints of abdominal tenderness for about 9 days on 12/12.  Was diagnosed with gastroenteritis and discharged home.  Normal CT scan at that time.  Presented again to the ED and was found to have fevers and transaminitis.  CT scan showed  left portal and right anterior portal vein thrombosis requiring admission and further workup. Patient was discharged on rivaroxaban for anticoagulation for at least 3 months and will have a follow up CT scan.
pt recv vax 13AUG98 mom called office 20AUG98 to say child had chickenpox;vesicles in mouth-scalp & genital area;using DPH & Niagra spray starch per MD;
Fever, chills, headache, body aches, joint pain, redness and inflammation at  injection side, with slight itch  Took Tylenol starting Noon 9/30/21 and stopped at 9am on 10/1/21  Symptoms began at 12 noon 09/30/21 Symptoms ended at 9am 10/1/2021
100 degree temp for 1-2 days, Full body rash for one week after temp subsided
The patient felt extremely warm, jittery, her heart was racing, and her face was swelling 10 minutes after receiving the vaccine. Her face swelled slightly and her arm had shooting pain up and down. The symptoms started with dry mouth and a weird taste in her mouth. That sensation continued for approximately 30 minutes.