chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dose given >12 hour post-puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose given >12 hour post-puncture) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose given >12 hour post-puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose given >12 hour post-puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date and time vial was first punctured: 12Mar2022 at 10:18 AM The vial was stored post puncture at room temperature. No concomitant and treatment medication were reported. The vial did not undergo any temperature excursions. The vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) for 24 hours.
This spontaneous report was received from a pharmacist refers to a two patients of an unknown age and gender. The patient's past medical history and concomitant medications were not reported. On 16-JUN-2017, the patients were vaccinated with 2 expired doses of PROQUAD (lot # M044719, expiry date 07-MAY-2018, dose, frequency route unknown) for prophylaxis. No further information was provided. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1707USA000203.
Post vax the patient experienced an anaphylactic reaction to the vaccine. Medical attention was sought and the reporting physician felt the reaction was related to the MMR vaccine. On 03/29/1996 the patient experienced a high fever of 104.8F. She was less active, was crying and whining although she had been taking fluids and wetting her diaper. There was no vomiting or diarrhea. The physical examination was normal. The patient was treated with ibuprofen. No further information is available.
local redness, swelling & heat;no treatment given;resolved w/in 48hr of vax;
pneumonia; chills; fever; head ache; body ache; This is a spontaneous report from a contactable consumer (patient). This 71-year-old female patient received the 3rd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 06Oct2021 at 12:00 PM at age of 71 years old as single dose for COVID-19 immunization; influenza vaccine (FLU) via an unspecified route of administration in the right arm on 06Oct2021 for immunization. Medical history included High blood pressure, high cholesterol. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included diltiazem, atorvastatin, citalopram, pantoprozole, received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 04Feb2021 at 12:00 PM at age of 71 years old, the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, both for COVID-19 immunization. The patient had covid test post vaccination with blood test on 12Oct2021 and the covid test result was negative. The patient developed chills, fever, head ache, body ache and pneumonia on 07Oct2021 at 12:00 AM. AE resulted in Doctor or other healthcare professional office/clinic visit. Treatment with antibiotics was received for the events. Outcome of the events was recovering. This report was reported as non-serious.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
45 yo male told us that "He can feel the vaccine  going through his arms and legs" 15 minutes after he received second dose of Moderna vaccine.   He could not described more details about the sensation, but said it was not pain nor numbness.   We asked him to stay longer in the wait area.  5- 10 minutes later, he told us he felt fine and left.
2 days later URI-cough, post nasal drip turned to sinus infection with peri orbital swelling of left upper lid -began treatment on with augmentin and dexamethasone started on 5/28/2022
little bump on (L) deltoid 3x3 mm Red area 7x6mm. This area is 9 mm above the main area of redness and warmth. An area of slight swelling, warm and redness is 70 x 58 mm. States arm is numb, hurts to move the arm pain with both lateral and verticle movement. Tx ice pack
child aged 12 y.o. with MINOR consent for first dose Pfizer, received pedi dose first dose Pfizer vaccine instead of adult dose. Vaccinator scratched through pre-stamped lot # and dose and changed it to another Lot # (which is non-existent) and changed dose to 0.2ml.
Approximately 36 hours after injection, pt experienced a high fever, sensitive skin (unable to touch it) joint stiffness, headaches, blinding headaches. After five years pt began experiencing deterioration of jaw bone and face. Pt hasn't been well since 1985. Was discharged with no benefits, no medical care. For the annual follow-up the pt states that the pt has the granulomatosis in a limited part, only lungs up. No kidney failure to date.
Left eyelid swollen and purple; Sharp pain on her left eyelid; Very weak and fatigued; Very weak and fatigued; This is a spontaneous report from a contactable consumer. A 65-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered in Deltoid Right on 28-JAN-2021 16:00 at single dose for COVID-19 immunisation. Patient medical history included COVID-19 Virus and diabetes runs in family, but she just had a physical. Patient did not have diabetes. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 29 Jan2021, the patient had experienced very weak and fatigued very weak and fatigued. On 30 Jan 2021, the patient had experienced sharp pain on her left eyelid. On 31 Jan 2021, the patient had experienced left eyelid swollen and purple. Next COVID-19 Vaccine in 18Feb2021. The patient did not received other medications within 2 weeks of vaccination. Patient was not on any prescription or over the counter medications. She took Eye Relief Eye drops and Benadryl for her eyelid swelling. Benadryl and Eye Relief eye drops did not do anything for swollen eyelid. Provided, lab-1451-1.0, on back of fact sheet for recipients and caregivers. On an unspecified date in 2021 the events sharp pain on her left eyelid and very weak and fatigued was resolved. At the time of reporting, the outcome of the event left eyelid swollen and purple was not recovered..
This patient contacted the Vaccine Healthcare Center to report the development of ankylosing spondylitis, symptoms which started during his employment. He is reporting the condition to the VHC because he is aware of several other cases of AS that have developed in temporal association to the receipt of the anthrax vaccine series. Patient had been employed for 13 years. He was clinically well when he started in May '09. He reports the following chronology of events: - He received anthrax #1 on 15 Apr '09, anthrax #2 on 17 Jul '09, and the smallpox vaccine on 9 Sept '09. - While traveling in Oct '09 he developed a febrile gastroenteritis determined to be food poisoning for which he received several liters of IV fluids. - Received the H1N1 vaccine on 20 Nov '09. - Experienced a 2nd similar febrile illness in country (approximate date?). - In Jan '10 he sustained a fall after which he developed continued back pain which radiated down the legs. - Exposed to multiple traumatic events and losses. - Experienced unrelenting back pain which progressed to the hips, shoulders, neck, knees and ankles throughout his employment until Jun '10. He was diagnosed with ankylosing spondylitis in Jun '10 after bilateral sacroiliac joint inflammation was found on MRI along with a positive HLAB27. He is currently in ENBREL for disease control but continues to experience flares.
shakes 10min p/vax p/getting something to eat;h/a, feverish, weak approx 1hr p/vax;chest pressure, vise approx 1 1/2hr p/vax w/lt arm pain w/tingling, heart had hard beat;? skipping;ER visit;
Pt present for 2nd dose of Moderna, reports that approximately 4 hours after 1st dose he developed hives primarily on his back and a "tickle" in his throat. Pt reports that he contacted his pcp, who prescribed a steroid dose pack and instructed him to take an antihistamine. Pt reports that symptoms resolved over a "couple of days" and didn't need further intervention.
Child received 1 dose of Tdap instead of Dtap.Mother states child has had no symptoms other than being "crabby" the night she was vaccinated
covid arm, fever, head ache, body aches, fatigue,  - for both shots
my heart rate kept dropping randomly and has been off and on high and low; stomach cramps; chest discomfort; Headaches off and on.; fatigue; Not able to eat and be active due to this; Had a rash three days later on my thigh near my knee; This is a spontaneous report from a contactable consumer (patient). A 38-years-old female non-pregnant patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Formulation: Solution for injection, Batch/Lot Number: 8735), via an unspecified route of administration, administered in Arm Right on 14Apr2021 16:30 (at the age of 38-years-old) as dose 1, single for COVID-19 immunization.  Medical history included benign arrhythmia from an unknown date and unknown if ongoing. Concomitant medications included ascorbic acid, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, magnesium, malpighia glabra fruit, manganese, molybdenum, nicotinamide, pantothenic acid, phytomenadione, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTIVITAMIN ACTIVE WOMAN) taken for an unspecified indication, start and stop date were not reported. The patient previously took moldamin and experienced hypersensitivity, dusta and experienced hypersensitivity, hydrocodone and experienced hypersensitivity. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine, the patient received womens multivitamin within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination the patient had not been tested for COVID-19. The evening of the vaccine patient's heart rate kept dropping randomly and had been off and on high and low. She had stomach cramps and chest discomfort off and on for two weeks now. Headaches off and on. Not able to eat and be active due to this. Patient have had not yet reported this to her PCM Will be reporting to her for advice. She had been having fatigue that comes and goes as well on 14Apr2021 22:00. Had a rash three days later on her thigh near her knee on unspecified date in Apr2021. Not sure if this was at all related, but due to the rash she later learned this had been reported and figure she would report her symptoms if there was a small chance of reaction or helping with data. There was no prolonged hospitalization. The outcome of all events was recovering.  No Follow-up attempts are needed. No further information expected.
Excessive vomiting 6-8 hours after immunization -which lasted overnight some resolved spontaneously. ZOFRAN prescribed PRN.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXEMIA
Headache, Myalgia, soreness at injection site Narrative:  Per nursing report: received injection on 2/10/2021; c/o Headache, throat and neck pain, pain at injection site.  Other Relevant History:
I felt my tongue was still swollen with like ridges where the teeth are touching my tongue; I had anxiety; My tongue is pushing my teeth; Tongue felt really weird; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (Tongue felt really weird), SWOLLEN TONGUE (I felt my tongue was still swollen with like ridges where the teeth are touching my tongue), ANXIETY (I had anxiety) and TONGUE THRUST (My tongue is pushing my teeth) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M02A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN, OMEPRAZOLE, ESTRADIOL, CHORIONIC GONADOTROPHIN (PROVIGIL [CHORIONIC GONADOTROPHIN]), ATORVASTATIN, CALCIUM, COLECALCIFEROL, MAGNESIUM (CALCIUM MAGNESIUM + VITAMIN D3), LORATADINE, ALPHA LIPOIC ACID, MACROGOL 3350 (MIRALAX) and VITAMINS NOS for an unknown indication.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PARAESTHESIA ORAL (Tongue felt really weird). On 27-Feb-2021, the patient experienced SWOLLEN TONGUE (I felt my tongue was still swollen with like ridges where the teeth are touching my tongue), ANXIETY (I had anxiety) and TONGUE THRUST (My tongue is pushing my teeth). On 05-Apr-2021, SWOLLEN TONGUE (I felt my tongue was still swollen with like ridges where the teeth are touching my tongue) had resolved. At the time of the report, PARAESTHESIA ORAL (Tongue felt really weird), ANXIETY (I had anxiety) and TONGUE THRUST (My tongue is pushing my teeth) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication included steroids (prednisone), 6 tablets to take by mouth, 1 tablet three times a day for two days, and was asked to take Zyrtec (Cetirizine HCL) 10 mg by mouth twice a day, doctor provided patient with an EpiPen, Medrol Dosepack (Methylprednisolone). No lab data was provided by the reporter.   This case was linked to MOD-2021-089433 (Patient Link).
A report has been received from a physician via sales concerning a 3 year old male patient. The patient's medical history and concurrent disease were not provided. The patient's concomitant medication was not provided. The patient received nasal FLUMIST. The physician reported that a 3 year old male patient experienced severe vomiting within 48 hours that lasted one day. At the time of report, patient had recovered from the event. The reporting physician assessed the causality between the event of Severe vomiting within 48 hours/one day and the suspected vaccine FLUMIST to be related.
loss my sense of smell; loss my sense of  taste; This spontaneous case was reported by a non-health professional and describes the occurrence of ANOSMIA (loss my sense of smell) and AGEUSIA (loss my sense of  taste) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 016B21A) for COVID-19 vaccination.     The patient's past medical history included Cellulitis from 19-Aug-2021 to 24-Aug-2021 and Hysterectomy in July 2008. Concurrent medical conditions included Pseudomyxoma peritonei (surgery) since 28-May-2008, Lichen sclerosus (Honey) since 22-Nov-2012, Laryngopharyngeal reflux since 10-May-2014, UTI (Antibiotics) since 05-Nov-1964, Asthma (Allergy shots) since 12-Feb-1975, OA knee, Allergy to antibiotic (Flagyl allergy), Peanut allergy (Peanuts allergies), Bee sting hypersensitivity (Bee stings allergy), Drug allergy (Oral steroids allergy), Allergy to topical drugs (topical steroids allergy), Allergy to antibiotic (clindamycin allergy), Drug allergy (macrodantin allergy), Drug allergy (decongestants allergy), Allergic reaction to analgesics (dilaudid allergy), Drug allergy (Antihistamines allergy minus), Allergy to nuts (Allergy to all nuts), Allergy to antibiotic (Allergy to cipro), Allergy to antibiotic (Augmentin allergy) and Drug allergy (Sulfa allergy). Concomitant products included SULFAMETHOXAZOLE, TRIMETHOPRIM (XANAX) for Muscle spasm, SIMETICONE (GAS X) for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ANOSMIA (loss my sense of smell) and AGEUSIA (loss my sense of  taste). At the time of the report, ANOSMIA (loss my sense of smell) and AGEUSIA (loss my sense of  taste) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatments was provided by the reporter.   This case was linked to MOD-2021-321274 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: First and second dose information,Historical conditions, current conditions, Allergic status Concomitant medications were added.
This spontaneous report as received from an approximately 76 years old male patient with thyroid disease, neuropathy and gluten allergy refers to himself. The patient's medical history included prostate cancer 12 years ago. The patient was vaccinated SC. with a dose of ZOSTAVAX (lot number unspecified"about 4 years ago", in approximately 2008. No other co-suspects were reported. Concomitant medications included SYNTHROID, calcium and vitamins (unspecified). The patient reported that, about 2 and and half years ago, in appropriate March 2010, he was diagnosed with neuropathy in the lower extremities causing him numbing and pain. He also said he was being considered for celiac disease. He broke out in blistering type rash on his upper body mostly and seemed to get better with a gluten free diet. The outcome of neuropathy in the lower extremities and celiac disease was unknown. The patient had sought unspecified medical attention. Patient did blood work very often and other studies for Neuropathy. Additional information has been requested.
Patient had flushing/sweating, dizziness. Patient stable & released from vaccination site.
acute myocarditis - presented to ER 1/17/2 for chest pain, sob diagnosis  trops peaked 23.29, CRP 14.33 echo mild anteroseptal and inferior wall hypokinesis  CTA Coronary calcium score 0 Cardiac MRI suggestive of Myopericarditis  repeat MRI in 6-8 wks no exercise    Symptoms started after Moderna booster. Had Pfizer for initial 2 Covid Vaccines
her blood sugar up so high; This is a spontaneous report received from a Pfizer-sponsored Program. A contactable consumer (patient herself) reported that a 53-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), via unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history included type 1 diabetic. Concomitant medications were not reported. It was reported that the patient spoke to the two departments and did not wanted to be on hold again as she was on hold for 2.5 hour. It was further stated that she received her first dose of the Pfizer COVID vaccine last Friday and blood glucose went up so high. She wanted to know what is in the vaccine that made it go high. Outcome of the event was unknown.   Information on the Batch/Lot number has been requested.
TOOK AN UNREFRIGERATED DOSE OF VIVOTIF; A spontaneous case report was received from a physician on 04-Jun-2019 for two consumers.  Based on the information obtained from the physician, two individual case safety reports PVX201906-000454 (PVX2019-1437; son) and PVX201906-000455 (PVX2019-1438, daughter) were created and cross-linked in the database.  This case describes a male consumer who "took an unrefrigerated dose of Vivotif". He was receiving Vivotif for an unknown indication.  Case report: The consumer took an unrefrigerated dose of Vivotif on 02-Jun-2019. He had no side effects.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took an unrefrigerated dose of Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took an unrefrigerated dose of Vivotif" was considered as not applicable. US-PaxVax Berna GmbH-PVX201906-000455:
After vaccine was administered, patient felt dizzy, vision was a little blurry. Patient sat on cot and ice pack was applied to back of neck. Vitals taken. Patient sat in EMS room approx 12 minutes until stated feeling better. Had patient stand to check balance and dizziness. Patient stated she felt good. Walked with patient and her mother to exit.
Received 2 doses of Fluzone High-Dose Quadrivalent flu vaccine within 30 days with no reported adverse event; Initial information received on 18-Jan-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who received 2 doses of fluzone high-dose quadrivalent flu vaccine within 30 days with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (strength, form, lot number, expiry date: unknown) via unknown route in unknown administration site for immunization.  On 02-Nov-2022 the patient had a non-serious event of received 2 doses of fluzone high-dose quadrivalent flu vaccine within 30 days with no reported adverse event (inappropriate schedule of product administration) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken with QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) was not applicable.  Outcome: Unknown.    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 the guidelines. 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.