chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He has been complaining about nausea; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 13 year-old male patient received bnt162b2 (BNT162B2), administration date 02Feb2022 (Lot number: 33036bd) at the age of 13 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. The following information was reported: NAUSEA (non-serious) with onset Feb2022, outcome "not recovered", described as "He has been complaining about nausea"; FATIGUE (non-serious) with onset Feb2022, outcome "not recovered", described as "Fatigue". The events "he has been complaining about nausea" and "fatigue" were evaluated at the physician office visit. Therapeutic measures were taken as a result of nausea, fatigue.  Additional Information: Pfizer Safety hopes that the child is feeling much better. Thank you for reporting the below information to safety on (SRD) 10Mar2022, with the first Pfizer Awareness Date (PRD) 23Feb2022. Since the information was reporting outside of the 24-hour compliance period for AE reporting we are actioned to follow-up on the delayed AE report. Please provide a reason for the delay in reporting and confirm completion of AE reporting training. Please also confirm understanding reporting responsibilities and the compliance timelines. We file this in the event that the documentation is required during an audit.  Response: Something I didn't specifically say in the report is that (Name) is my son. The reason for the delay is distinguishing between expected immune response to the vaccine and an adverse event. So while I listed the date he got the vaccination as the date of the adverse event I did not view it as that on 23Feb. I viewed what was happening as the expected immune response. Defining the date when I first became aware of the event wasn't straight forward so I just picked the day he got the 2nd dose of the vaccine. What triggered me to report it as an adverse event is when he came home on 10Mar and told me about his sharp pain because that seemed to be going the wrong way in recovering.  Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care. The patient did not received any other vaccine within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Ibuprofen. Treatment received for adverse event was prescribed antacid and referral to GI specialist. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no known allergies. No medical history.  No follow-up attempts are possible. No further information is expected.
Moderna COVID?19 Vaccine EUA 2/13/2021: chills, fever (101-102), body aches, headaches and slight nausea.  Treated at home with tylenol. 2/14/2021: fatigue, slight dizziness. 2/15/2021: Asthma flare up, used rescue inhaler 2/17/2021: Eyelid swelling, itching, discharge.  Went to Urgent Care and was diagnosed with an allergic reaction.  Was given 60 mg of 60 mg prednisone, benedryl then took 20 mg of prednisone daily for 5 days. 3/2/2021: Eyelid swelling continue.  Went to primary care doctor and was given erythromycin ophthalmic oinment usp .5% to use for 10 days .
This literature marketed report as received from the authors of the published article refers to an 89 year old female patient with arterial hypertension and mild cognitive impairment. The patient was otherwise very functional and independent. She was immunocompetent. In 2009 she received zoster vaccine (manufacturer unknown) (dose, route of administration, lot# and expiration date not reported). In early 2013, she developed sudden onset pain over her right hemithorax, which extended in a half-belt fashion from below the lower portion of the scapula, radiating forward along the right costal margin co the right upper quadrant of the abdomen. The pain was a constant, deep burning sensation that was not associated with meals and worsened at night. Analgesics, antacids, or bowel movements did not relieve it. It was made worse by touching the affected area, even by the rubbing of her clothing. There were no skin abnormalities present. The patient presented to her local emergency room, where the workup included ultrasound and computerized tomography (CT) scans, both of which were noncontributory. She was discharged home with no additional treatment other than analgesic agents. She returned to geriatric primary care clinic 7 days later, because the pain and discomfort were not resolved. Again, the work up was unrevealing. She was given a prescription for codeine plus acetaminophen. She returned to the geriatric clinic within 10 days, because her pain was unchanged. Again, other than the very sensitive area on her thorax, there were no signs of a rash or other abnormalities. A broader set of diagnostic laboratory tests were performed, including a polymerase chain reaction (PCR) for Varicella Zoster Virus. The patient was ultimately diagnosed with herpes zoster shingles variant, zoster sine herpete, on the basis of her clinical presentation and the description of her pain. Her differential diagnoses initially included liver and/or gallbladder disease or radiculopathic pain. Because an etiology for her pain was not determined at presentation, treatment was delayed for several weeks, during which she endured significant discomfort. The fact that she had received the zoster vaccine (manufacturer unknown)  may have suppressed the appearance of the shingles rash, which would have provided a strong clue to the diagnosis. By the time serologic studies were reported as positive for VZV, more than 3 weeks had elapsed since her initial presentation. Because the area was still very painful, she was treated with prednisone (manufacturer unknown) 40 mg per day and tapered over a 2-week period. In addition, she received gabapentin 200 mg three times per day for 6 weeks. She reported significant pain reduction within 1.5 weeks. Three months later, she was symptom-free, suggesting she was not affected with post-herpetic neuralgia. The authors concluded that when shingles occurs despite vaccination, the extent of the rash and the severity of neuropathic pain may be less.
Hardness Near the Injection Site; Itchy Sensation - Near Injection Site; Hot to Touch - Near Injection Site; Swelling - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to Touch - Near Injection Site), VACCINATION SITE SWELLING (Swelling - Near Injection Site) and VACCINATION SITE INDURATION (Hardness Near the Injection Site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Claritin. Concomitant products included Allergy Shot                                                   Allergies and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to Touch - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site). On an unknown date, the patient experienced VACCINATION SITE INDURATION (Hardness Near the Injection Site). At the time of the report, VACCINATION SITE WARMTH (Hot to Touch - Near Injection Site) and VACCINATION SITE SWELLING (Swelling - Near Injection Site) outcome was unknown.        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.
15 days post vax the pts mother noticed one quarter sized red wheal at the injection site. The wheal was described as gigantic spot on right arm at injection site. Looks like a bite, red and is quarter size. It was noted that the pt was afebrile. The pt sought unspecified medical attention. It was indicated that the pts mother was advised to apply warm compresses on the pt as well as administer Benadryl. Additional information has been requested.
Awoke at 2:30am with uncontrollable shaking and extremely cold. Arm so swollen he could not move. Had Back Pain, swelling in groin and back of knees.
No additional AE reported; an improperly stored GARDASIL 9 was administered; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, drug reactions or allergies were not reported.   On 04-FEB-2021, an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1687292 with expiration date: 25-AUG-2022) for prophylaxis was administered to the patient (product storage error). The dose, strength and route were not reported. No additional adverse event (AE) reported.  Administered dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) experienced the temperature excursion under 35 degrees Fahrenheit (F) for 15 minutes. There was no previous temperature excursions reported. The digital data logger was involved to capture the temperature excursion. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Lip swelling; facial swelling and Cheek swelling; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 06Apr2021, as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 06Apr2021, an hour after the vaccine,  the patient noticed her cheeks felt they were swelling. On 7Apr2021, the patient had minor swelling on her lips. The patient would like to know, if this is a common side effect after the vaccine. The outcome of the events was unknown at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working  on a compliance improvement plan and has been reinstated vaccination privileges.
This spontaneous report as received from a registered nurse refers to a 19 years old female patient. The patient had a history of syncope after receiving a vaccinations. On an unknown date in approximately June 2015 (reported as "about one month ago"), the patient was vaccinated with the first dose of GARDASIL 1 injection, first dose of three dose series (dose, lot # and expiration date were not reported). Concomitant therapies administered during the same visit included TDap and MENACTRA. On an unknown date in approximately June 2015 (reported as "after the product was administered"), the patient experienced syncope. She also experienced a "bit of snorting respiration" but it was "not enough to qualify as a seizure or convulsion". The patient was revived with ammonia inhalant. The patient's father was with her and mentioned that this happened each time she got a vaccine and thinks it had to do with her level of anxiety about "receiving the shots". It was not specified if the patient plans to complete GARDASIL series. The outcome of the adverse events was reported as recovered (unspecified date). The causality between the adverse event and GARDASIL was not provided. Additional information is not expected as the reporter did not wish to be contacted.
10/15 8:00 PM cough, 1:00 AM skin tingling all over. 5:00 Am very fine rash all over. Cough and fine rash continued until 10/17 early in the AM started with hives and cough worsened. During the night 10/13 into early morning SOB 2 times and around 8:00am my face and tongue started to swell. I went to the doctors on the 21st at 11:15AM and started on a prednisone taper, cough medicine and using hydrocortisone cream. On the 23rd I still have hives on 60% of my body and lost a day of work.
bit of shortness of breath; burping a lot at night; finger hurt; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (bit of shortness of breath), ERUCTATION (burping a lot at night) and PAIN IN EXTREMITY (finger hurt) 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 DYSPNOEA (bit of shortness of breath), ERUCTATION (burping a lot at night) and PAIN IN EXTREMITY (finger hurt). At the time of the report, DYSPNOEA (bit of shortness of breath), ERUCTATION (burping a lot at night) and PAIN IN EXTREMITY (finger hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
RN accidently gave Pfizer Pedi Bivalent instead of monovalent for first dose - error noted when trying to document vaccine and lot#   not listed in system.  Father notified of error and Covid card updated to show Bivalent vaccine given
A report has been received from a physician concerning a 10-year-old female patient. Relevant history and concomitant medication was not reported. On 10-Jan-2014 the patient started therapy with nasal FLUMIST QUADRIVALENT (intranasal) for unknown indication. On 13-Jan-2014 the patient was tested positive for flu after FLUMIST QUADRIVALENT and presented with symptoms of fever and cough. The action taken of FLUMIST QUADRIVALENT was not applicable. The outcome of the event of tested positive for flu, fever and cough was unknown. The reporter considered the event of tested positive for flu to be non-serious. The events of fever and cough have been identified by the company physician from the source documents and added as adverse events and assessed them as non-serious.
Information was received on 09-NOV-2016 from an unspecified reporter, regarding a patient of unknown age and gender. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient  was vaccinated with an improperly stored dose of RECOMBIVAX HB (strength, dose and route were not reported) with lot number M007763 (unspecified expiration date). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected.
Pt, Very anxious, dizziness,chest tightness. Vital signs taken 150/90 p80 r 16 145/100 80 r 16 160/100 p 81 r16 157/90 p 78 r16
First day itching and red round area surrounding the injection site.  I took Zyrtek and applied Cortaid cream to the area. Second day, injection site red and very warm,  dull headache all day.  Late afternoon and evening body aches - temperature 98.7 degrees.  I took aspirin and another Zyrtek.  3rd day feeling tired, but fine.  The site of the injection is still red and not longer round.  It is spreading   slightly upward and downward.
COVID 19; COVID 19; vaccine brand=Pfizer / BioNTech; vaccine brand other=Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 at 16:00 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Mar2021 at 12:15 as dose 1, single (Lot number: 014M20A), in left arm, on 08Apr2021 at 14:30 as dose 2, single (Lot number: 006B21A), in left arm, on 27Aug2021 at 14:30 as dose 3 (booster), single (Lot number: 045B21A), in left arm and on 08Sep2022 at 12:15 as dose 5 (booster), single (Lot number: AS7143C), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Apr2022 at 16:00, outcome "unknown", described as "vaccine brand=Pfizer / BioNTech; vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: at-home test.The patient was treated with Paxlovid from 26Feb2023 to 03Mar2023.
No problems on the first day.  The next morning I woke with a low grade fever, chills, and a headache.
General fatigue; Joint Pain; Muscle pain; Headaches; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (General fatigue), ARTHRALGIA (Joint Pain), MYALGIA (Muscle pain) and HEADACHE (Headaches) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced FATIGUE (General fatigue), ARTHRALGIA (Joint Pain), MYALGIA (Muscle pain) and HEADACHE (Headaches). At the time of the report, FATIGUE (General fatigue), ARTHRALGIA (Joint Pain), MYALGIA (Muscle pain) and HEADACHE (Headaches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  The patient provided consent to follow-up, but does not have an HCP (health care provider).
Dizziness, pt stated that she was feeling tired, faint, could not walk, almost passed, pale face, low blood pressure. But she was conscious the whole time. The whole episode happened about 10 minutes after receiving the vaccines. She was monitored in the office until she was feeling better. She walked out of the office at 1230 PM. Received the shots at 1140.
Provider told me my platelet count was low and to stop donating platelets (July/2021) Annual Physical blood work showed platelets, WBC and neutraphils were below normal range (Dec /2021)  Referal to Hemotologist Hemotogist observed for 9 months. Blood work continued to be below normal range for platelets, WBC and neutraphils.  No treatments were administerd. Annual Physical blood work showed platelets, WBC and neutraphils still below normal range. 2nd hemotologist was referred. (11/2022) Under Dr. care, one iron infusion treatment (3/13/2023 &  3/16/2023).  Bone marrow biopsy for suspect pancytopenia (procedure done on 4/27/2023).
Employee received the second dose of the Pfizer COVID vaccine.  Employee felt deep bone and muscle pain right after injection.  The next day she was unable to move arm away from her body.  Took Tylenol and ibuprofen and range of motion improved.  Over time pain increased to a constant pain.  On 2/14/21 the pain increased to 7 out of 10 while she was laying down and the pain would wake her up at night.  Employee reports pain was bad regardless if she was sleeping on right arm or not.  Employee reports one day (2/7/21) she experienced numbness in right arm down to fingers tips.  Employee was seen on 2/18/21 and was diagnosed with rotator cuff tendonitis and prescribed physical therapy and given a steroid injection: methylprednisone acetate.
redness and swelling at injection site; redness and swelling at injection site; This is a spontaneous report obtained from a contactable physician through a sales representative. This physician reported similar events for two patients. This is the second of two reports.   A patient of an unspecified gender and age received PREVENAR 13, Solution for injection in pre-filled syringe via an unspecified route of administration, at single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced redness and swelling at injection site. Clinical outcome of the adverse events was unknown at time of this report.   No follow-up attempts are possible, information about lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020341302 same reporter/ drug/ event for different patients.
sore arm and redness, swelling  and warmth (expected) not expected - extreme weakness, shivering, very cold, headache, fever 102.4
Inconsolable screaming crying that evening.   Head size swelling .  Increased from 30 percentile to 80 percentile by next well visit.  Left eye crusted and discharge.
Severe left arm pain and swelling; Severe left arm pain and swelling, Severe leg and feet , stomach swelling; Stomach swelling; Severe migraines; Extreme blurry vision; Severe body and joint pain; Severe body and joint pain; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 11Apr2021 at 12:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included glaucoma, spinal injuries, high blood pressure, hypertension, medical doctors advised the patient not to get flu vaccine because patient's mother was paralyzed from Guillain barre syndrome (possibly from flu vaccine) and known allergies to latex and food allergies but they went away. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 12Apr2021 at 05:00, the patient experienced severe left arm pain and swelling severe leg and feet, stomach swelling, severe migraines, extreme blurry vision and severe body and joint pain. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe left arm pain and swelling, severe leg and feet, stomach swelling, severe migraines, extreme blurry vision and severe body and joint pain were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient reports have severe arm pain in lower deltoid region. Claims she could hardly move her arm after vaccination and for a week afterwards. The pain has gradually gotten better but patient still struggles to lift arm past her shoulder line or reach forward without pain.
Pt presents to ER with a 5 day history of left lower extremity swelling without significant pain.