chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness, mild swelling 3" in diameter on right mid-thigh, minimal warmth without fluctuance, 48 hours, post vax of Trihibit. RX: Augmentin but doubt cellulitis.
No adverse event; she got all 3 shots bivalent, and she already had received the booster for 2021 and got it again yesterday.; This spontaneous case was reported by a patient and describes the occurrence of EXTRA DOSE ADMINISTERED (she got all 3 shots bivalent, and she already had received the booster for 2021 and got it again yesterday.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 Vaccine (Booster) in 2021. Past adverse reactions to the above products included No adverse event with Moderna Covid-19 Vaccine.    On 20-Jun-2023, 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 20-Jun-2023, the patient experienced EXTRA DOSE ADMINISTERED (she got all 3 shots bivalent, and she already had received the booster for 2021 and got it again yesterday.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (she got all 3 shots bivalent, and she already had received the booster for 2021 and got it again yesterday.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (she got all 3 shots bivalent, and she already had received the booster for 2021 and got it again yesterday.).    No concomitant information was reported. Suspect product dosage text was reported as unknown. It was reported that patient had 3 shots bivalent, and she alreadyhad received the booster for 2021 and got it again yesterday. It was reported that patient gave her son card instead of her card. No treatment information was provided.
Weakness; Painful stomach; Malaise; This is a spontaneous report from a non-contactable consumer, the patient. A 55-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 26Feb2021 at 08:00 (at the age of 55-year-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (Afib), obesity, high cholesterol and hypothyroidism start from an unknown date, unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medication included drug not specified too many to list (as reported). On 27Feb2021 at 20:00 the patient experienced weakness, painful stomach and malaise. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events weakness, painful stomach and malaise were recovering at the time of report.  No follow-up attempts are possible. No further information is expected.
chest tightness, throat tightness, itching, headache, and nausea, which are consistent with her usual anaphylaxis symptoms with first COVID-19 mRNA vaccine IM.  Called RRT. Taken to ED. Took diphenhydramine 50 mg PO. Patient had an EpiPen, but wanted to wait to see if diphenhydramine worked. Symptoms improved over 20 minutes. Observed patient until fully resolved. Instructed patient to return to ED if symptoms worsened or returned.
This case was reported by a healthcare professional and described the occurrence of maladministration (asymptomatic/child too young) in a 4-month-old subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). On 14 May 2012 the subject received 2nd dose of KINRIX (unknown) and experienced maladministration (asymptomatic/child too young). The nurse reported two 4-month-old subjects were administered KINRIX on 14 May 2012. KINRIX is not indicated for this age (too young). The nurse reported the subjects were taken to the emergency room by the mother because "the mother was very concerned that something might happen". The nurse reported "that from her knowledge the subjects were fine, and they were not admitted". At the time of the report no other information was available. This is case one of two, for the second case see A0977580A.
Pt developed rash approximately 2-3 hours after receiving MMR/Varivax/PCV13. A fine erythematous rash on trunk and upper extremities with some patches on face. No rash present at injection sites.
The area of injection left deltoid pt reported his arm became red, itchy and swollen on the 7th day after the shot; it remained that way for 3-4 days and disappeared completely.
Patient discovered marble-sized lump on right side of neck. Ultrasound performed (sonography) of the right and left posterior neck regions. At the time of the test (5 weeks after doctor's visit) the lump is significantly decreased in size and is now barely palpable. A small lymph node is noted measuring 1.0 x 0.4 x 0.4 cm.
A report was received from a healthcare professional on 31Oct02, concerning a 48 year old female vaccinee who experienced back pain, lethargy, loss of appetite, insomnia, feet pain, hand pain and arm pain, approximately 72 hours after receiving Fluvirin on 25Oct02. On 28Oct02, the vaccinee experienced left arm pain (the injection arm) and then right arm pain. The pain continued in her arms and later included the palms of her hands. As a result of the pain, the vaccinee sought medical care at a local ER on 27Oct02 at 11:00PM. The feet, hand and arm pain resolved on an unspecified date. The vaccinee continued to experience back pain, lethargy, loss of appetite and insomnia up to 31Oct02. The vaccinee was scheduled for a follow up visit with her physician on 31Oct02. The reporter has assessed the relationship of the vaccine to the event as possible. Update 1, 22Jan03, A report received from a health care professional indicated that the vaccinee also experienced flu-like muscular aches and chills on 25Oct02, neuritis or nerve pains on 27Oct02, fatigue, muscle weakness, aches and stiffness on 29Oct02 and an upper respiratory infection on approx 09Nov02. The flu-like muscular aches and chills resolved on 26Oct02. The vaccinee was treated with an anti-inflammatory Naprosyn and amoxicillin, salbutamol, loratadine and fluticasone propionate for the respiratory infection. The neuritis or nerve pains, fatigue, muscle weakness, aches and stiffness had not resolved at the time of the report but had much improved. The upper respiratory infection had not resolved at the time of the report. The reporter has assessed the relationship of the vaccine to the flu-like muscle aches and chills, neuritis or nerve pains, fatigue, muscle weakness, aches and stiffness as probable and the upper respiratory infection to be presumed secondary to the compromised immune status of the vaccinee.
Narrative:  73 yo M with hx of peripheral vascular disease, HLD, and PTSD received two doses of moderna vaccine on 02/14/2021 & 03/11/2021. Pt died on 06/10/2021. Death is not likely due to vaccinations.
Patient received a third dose of the Pfizer covid-19 monovalent vaccine instead of the bivalent vaccine indicated for the 3rd dose indicated in the most recent guidance by the CDC.
This spontaneous case, initially received from other health professional (pharmacist) on 07-Nov-2018, concerns a 74-year-old, elderly, female patient. On 22-Oct-2018, at 12 pm, the patient was administered FLUAD (TIV) [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250806 and expiry date: 30-Jun-2019]. On the same day, few hours after vaccination, by 6 pm, the patient reported to the pharmacy with the symptom chest pain. At the time of the report, the outcome of the event was not reported. This reporter considered the case as non-serious.
Pt woke up from nap at 4 PM, throat was hurting had hard time to swallow, came down to clinic to get checked, tonsils were very swollen, lungs were clear. vitals were stable. consulted with Doctor, who said to treat with Epi-Pen 0.3 mgs, Diphenhydramine inj.  50 mg IM, Dexamethasone inj. 8 mg IM.  Dr and I were concerned about her airway, after half hour, pain wasn't as bad in her throat but still felt and looked swollen, so Dr activated a Medivac. Diagnosis was Possible allergic Reaction to the Moderna vaccine.
Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 19-FEB-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
severe adverse reaction to the first dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (severe adverse reaction to the first dose of the vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (severe adverse reaction to the first dose of the vaccine). At the time of the report, ADVERSE EVENT (severe adverse reaction to the first dose of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
BREATHLESSNESS; DIZZY; MAJOR DIARRHEA; SLEEPING ALMOST LIKE SHE WAS DRUGGED /DEEP SLEEP; SORE ARM; SEVERE NAUSEA; FATIGUE; HEADACHE; This spontaneous report received from a consumer concerned a 66 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced breathlessness. On APR-2021, the subject experienced dizzy. On APR-2021, the subject experienced major diarrhea. On APR-2021, the subject experienced sleeping almost like she was drugged /deep sleep. On APR-2021, the subject experienced sore arm. On APR-2021, the subject experienced severe nausea. On APR-2021, the subject experienced fatigue. On APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, headache, dizzy, breathlessness, severe nausea, major diarrhea, sore arm, and sleeping almost like she was drugged /deep sleep. This report was non-serious.; Sender's Comments: V0  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
did not receive 2nd shot; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The repoter asked did need to restart series over.
I received the first dose of the Pfizer vaccine on 4/10/21. Eight days later I came down with a bad case of the shingles (herpes zoster). This resulted in a very painful rash all around the right side of my body, from my spine to my stomach. I went in to my local urgent care on 4/20/21, where it was diagnosed as shingles, and I was prescribed Valacyclovir as an antiviral. As of today, 4/23/21, I still have a bad rash and pain.
Patient received a booster dose at a vaccine site out side of the recommended age of 18 and older.
a little lump that I had under my skin; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (a little lump that I had under my skin) in a female patient of an unknown age 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (a little lump that I had under my skin). At the time of the report, VACCINATION SITE MASS (a little lump that I had under my skin) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Pt received vaccines 7/11/14. 7/12/14 mother reports rash on left thigh where pt was administered varicella et KINRIX. 7/14/14- rash still currently present. No other symptoms.
The vaccines were possibly out of temperature due to the move, during hurricane. They were transported in the refrigerator provided by the department of Health with their respective blocks of ice, not accompanied by a thermometer.
I HAVE HEADACHES AND NAUSEA THAT WAX AND WANE SINCE I RECEIVED MY SECOND SHOT ON JAN 31ST. THE HEADACHES ARE PRESSURE HEADACHES THAT ARE MOSTLY ON THE TOP OF MY HEAD BUT CAN MOVE AROUND MY HEAD AND FACE. THEY RANGE IN SEVERITY FROM SEVERE AND INTERFERE WITH MY ABILITY TO THINK TO MILD AND ABLE TO FUNCTION BUT THEY ARE ALWAYS PRESENT. I WAKE UP WITH THE HEADACHES AND NAUSEA. MY NEUROPAHTY  ON MY LEFT ARM,WHICH RECEIVED THE SHOT, HAS GOTTEN WORSE WITH INCREASED TINGLING AND A FEELING LIKE A BAND IS SQUEEZING AROUND THE TOP PART OF MY ARM.
On 07/05/2006, severe headache, nausea, vomiting decreased mentation and unable to work.8/11/06 Received medical records from hospital which reveal patient admitted 7/5/06 w/dx: aseptic meningitis, thrombophlebitis at PICC line site, thrush, hyponatremia.  Patient is a physician, opththalmologist.  PMH: antiphospholipid antibody syndrome, mixed collagen vascular disease, GERD, anxiety, MVP, pericarditis, diverticulosis & coagulopathy.  Headaches progressed from 6/29 until admission.  Temp max 100.8.  Received antibiotics & antivirals until all c/s were neg.  D/C home on 7/11/06 on oral antibiotics & anticoagulants.  Patient was improved but still required Dilaudid for HA pain on d/c.  Consults done for ID, neuro, heme/ss
red at the injection site and it was about the size of finger nail; This is a spontaneous report from a contactable consumer or other non-health care professional.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on 23Aug2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced red at the injection site and it was about the size of finger nail on 24Aug2021. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
was crippled due to an adverse reaction; This case was reported by a consumer via interactive digital media and described the occurrence of gait inability in a child patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced gait inability. On an unknown date, the outcome of the gait inability was unknown.   It was unknown if the reporter considered the gait inability to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient got the vaccine and it was not mandatory where they lived. The patient was crippled due to an adverse reaction.
7/10 Pain; Localized swelling as well as in the distal phalanges of the right arm; No numbness.
TEMPERATURE EXCURSION OCCURRED DUE TO THE PLACEMENT OF HAND WARMERS IN THE INSULATED BAG USED TO TRANSPORT VACCINE. ALL 81 PERSONS RECEIVING VACCINE IN LANES 5 AND 6 AT THE MEDICAL CENTER ON 02/15/2021 BETWEEN 14:00 and 16:45 WERE NOTIFIED THEY  RECEIVED VACCINE THAT WAS OUTSIDE OF THE APPROPRIATE TEMPERATURE RANGE AND WERE RECOMMENDED TO BE REVACCINATED.
pt recv vax 1983 & immed p/vax pt converted enzymes & devel cirrhosis;the reporter felt the surgeon's exp was r/t therapy w/hep b vax;
Pt recvd vax & had a reaction; refused any further info; no further details were provided;
Tightness in the left breast several days. Thick palpable cord/ inflammation of vein.
Red and itchy rash at the site of shot. Applied Cortisone cream and calamine lotion. Also took Benadryl pill.
THE VACCINE ADMINISTRATION WAS DONE 2 DAYS AFTER THE BEYOND USE DATE (BUD). ONCE RECEIVED, VACCINES MUST BE STORED REFRIGERATED FOR UP TO 10 WEEKS. THESE VACCINES WERE RECEIVED ON JANUARY 26, 2022 AND THE BUD WAS APRIL 5, 2022. HOWEVER, UPON RECEIPT THE STAFF CONFUSED THE DATE AND DOCUMENTED THE BUD AS MAY.
Strong flu like symptoms the day of the vaccine and severe pain in my injection arm. About two days later a severe rash that looks like chicken pox developed on my stomach and back and is persisting and getting worse 6 days after initial symptoms or 8 days after injection.  Headaches and light fatigue happening since the night of injection.
Full syncopal episode lasting 15 seconds per vaccinator. Awake, alert and oriented upon med response arrival. Pt states hx of syncope with blood draws and injections. denies having breakfast today. Denies any food or drink from medical staff.  Symptoms resolved and pt left.
The vial was initially stored in the refrigerator on 10-JUL-2023 and administered to patient on 10-AUG-2023.; No adverse event; Dose administered after 30-day Use by Date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-JUL-2023 and administered to patient on 10-AUG-2023.) and NO ADVERSE EVENT (No adverse event) in an infant female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Aug-2023, 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 10-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-JUL-2023 and administered to patient on 10-AUG-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-JUL-2023 and administered to patient on 10-AUG-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use by Date.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 10-JUL-2023 and administered to patient on 10-AUG-2023.).    No concomitant medication was reported.  No treatment information was reported.  This case contains information for patient 2 out of 2.   This case was linked to US-MODERNATX, INC.-MOD-2023-737504 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737504:Patient 1
Child came for well child exam and stated school nurse stated she needed varivax.  Varivax administered that afternoon, school nurse called to inform MD.  She just found out child is pregnant.
This spontaneous report was received from a licensed nurse practitioner refers to an unspecified number of unspecified patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored GARDASIL (lot #, expiry date was not reported). No adverse event was reported. The outcome of the events were not reported. This is one of the several reports received from the same reporter. Additional information has been requested.
pt recv vax 14MAY97 & 19MAY97 pt woke up in the morning w/blood coming from nose;black & blue eyes;eyes & ears were swollen shut & had chills;