chrisvoncsefalvay/vaers-outcomes huggingface dataset:
113 Bivalent doses administered after the BUD to patients 12 and up.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up.).    No concomitant medicine were reported. No treatment medicine were reported.
LOW PLATELETS; This spontaneous report received from a patient concerned a 90 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included: transcatheter aortic valve replacement, and stoke, and concurrent conditions included: minor history of clotting, and other pre-existing medical conditions included: The patient had a strong immune system. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: 04-AUG-2021) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. Concomitant medications included cannabidiol. On an unspecified date, the patient experienced low platelets. Laboratory data (dates unspecified) included: Platelet count (NR: not provided) low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of low platelets was not reported. This report was non-serious.
Itching and sharp needle like pain on bilateral buttck and groin. No rash. Constant
Patient stated red sore area, hard, and blotchy at site of administration; described site of administration to be "near the armpit".
Information has been received from a licensed practical nurse concerning an approximately 4 year old patient who on 31-JAN-2005 was vaccinated with a dose of VARIVAX (Merck) (lot# 649848/0769P). On approximately 22-FEB-2008, the patient experienced 50 to 100 lesions. At the time of the report, the patients' outcome was unknown. This is one of several reports received from the same source. No further information is available.
After receiving the vaccine, I had the initial symptoms like a headache and arm soreness. Wednesday night at 9 o'clock, the bottom of my left foot was asleep and had a tingling feeling, like lack of circulation. The next day Thursdays, it was now on my right foot just not as bad. By Friday morning, I couldn't walk. My left foot was much worse than the right foot. I had to wobble around because I couldn't walk properly. By Friday afternoon, I went to an urgent care and the doctor said it could be a blood clot so she told me to go to the ER to check to see if I had a blood clot. I decided not to go to the ER and get that checked. On Monday I made an appointment with Dr. because it didn't get any better. I seen him and he said it is possible that this is a side effect of the vaccine. There was no test he could run on me so he  informed me to sit back and keep an eye on it. I have a follow up appointment with him on July 26th because the left foot at the bottom is still asleep and tingly.  I still have a tingly feeling in my right foot as well, but I am able to walk  now. About 2 weeks ago, I started to get a tingly feeling in the palm of my left hand. My feet has not got any better or worse. They are just tingling. I only had this happened to me after taking the 2nd dose because I have never had this issues before.
Premature Rupture of Membranes (water broke) at 31 weeks exactly as patient was compliant with bed rest for preterm labor a month previously. EDD 12/15/2018. Patient currently remains pregnant but will be hospitalized for remainder of pregnancy with birth scheduled for 34 weeks gestation if patient does not labor before then.
nurse accidentally administered Trumenba instand of Menactra / no AE; Initial information was received on 18-Jul-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 11 year old male patient who received MENINGOCOCCAL VACCINE B RFHBPA/FHBPB [TRUMENBA] instead of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and Expiry date unknown) via unknown route in unknown administration site for Prophylactic vaccination, on an unknown date.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered.  At the time of report, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  There will be no information available on the batch number for this case
Vaccine leaked from syringe, dose repeated. Dr. notified/event discussed with client.
Broke out in an itchy rash all over her body (legs, arms, torso). Had dry skin and discoloration on her legs. Took OTC allergy medicine and it helped with the itching. This lasted 3 weeks. She did not seek care, it ended up resolving on its own.
Information has been received from a RN concerning her 18 year old daughter with no known allergies who on 08/17/03 was vaccinated with a 0.5mg dose of hepatitis B virus vaccine rHBsAg (yeast)(Lot # 644386/0946M).  Concomitant therapy that day included a dose of tetanus toxoid.  On approximately 08/28/03, about 1 and 1/2 weeks later, the pt experienced erythema multiforme.  It was reported that the pt was not hospitalized and is not pregnant. Unspecified medical attention was sought.  No additional information was provided.  There was no product quality complaint.  Additional information is expected.
Headache for 2 days. Right arm pain. Mild case of shingles on right shoulder and right side of back  appeared to be a rash itched. Also a small amount of rash on left shoulder.
Early am Thursday 6/1 began feeling intense itching and had trouble sleeping.  Took Benadryl and applied hydrocortisone cream to injection site.  Friday am 6/2 she called her GP and was advised to go to urgent care if symptoms worsened.  Friday pm hives developed all over body - patient went to urgent care and received steroid shot.  She was dispensed a steroid dose pack Friday PM and took as directed.  Called pharmacy to report adverse event on 6/5/23.  She reported that her sympotoms were resolved at this time.
Accidentally administered a vial that was left outside of the fridge for more than 12 hours post punctured; A vial that was left outside of the fridge for more than 12 hours post punctured; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Accidentally administered a vial that was left outside of the fridge for more than 12 hours post punctured) and PRODUCT STORAGE ERROR (A vial that was left outside of the fridge for more than 12 hours post punctured) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Accidentally administered a vial that was left outside of the fridge for more than 12 hours post punctured) and PRODUCT STORAGE ERROR (A vial that was left outside of the fridge for more than 12 hours post punctured). On 11-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Accidentally administered a vial that was left outside of the fridge for more than 12 hours post punctured) and PRODUCT STORAGE ERROR (A vial that was left outside of the fridge for more than 12 hours post punctured) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. The vial was initially stored in the refrigerator on 01-Dec-2021. The vial was first punctured 10-Dec-2021 at 1PM. Post puncture the vial was stored in the fridge. The vial did not undergo any temperature excursions. No treatment medications were reported.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In October 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In July 2016, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles.  As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
BODY ACHES; FEVER; NASTY TASTE; dark urine; backache; heartburn; fatigue; This is a spontaneous report received from a contactable consumer(patient).  A 75-years-old female received second dose of BNT162B2 (BNT162B2, formulation: solution for injection, lot no: EL9267), via an unspecified route of administration in Arm Right as SINGLE DOSE for covid-19 immunisation on 12-FEB-2021. Medical history included Diabetes mellitus from an unknown date in 2002 and unknown if ongoing, gastroesophageal reflux disease from 2010 and unknown if ongoing, Gall bladder reflux surgery and blood cholesterol from 2014. Concomitant medication included farxiga (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) 10mg from 2018, esomeprazole sodium (ESOMEPRAZOLE SODIUM) 40 mg, Januvia (SITAGLIPTIN) 100 mg, montelukast (MONTELUKAST)-10 mg, atorvastatin calcium (ATORVASTATIN CALCIUM) 80 mg, hydrochlorothiazide(HYDROCHLOROTHIAZIDE) 12.5 mg. All the drugs are ongoing.On 13Feb2021, patient experienced body aches, fever, nasty taste, dark urine, backache, heartburn, fatigue. There was no treatment due to events. The  outcome of events were recovered.  No follow-up attempts are needed. No further information is expected.
L arm pain and minimal weakness began day of vaccine and persisted even to day of eventual appointment for eval on 12/18/2020.  Affected muscles most tender with hypertonicity:  deltoids, lat dorsi, supraspinatus, L scalene.  No:  fever, chills, erythema, or swelling.  b/l 1/4 pulses, b/l positive Adson's for possible TOS.  reflexes and sensation intact.  L shoulder PROM intact with 4/5 strength thought to be d/t pain. Treated with ibuprofen, ketorlac in urgent care, icing, brief OMT, topical voltaren, stretching, strengthening as tol, reassurance.   Has not resolved yet.
severe headache, bad bruising, extreme fatigue, very sore muscles, odd sensation in muscles in back bled terribly after injection
Red spots on the entire both legs for almost 3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red spots on the entire both legs for almost 3 weeks) in a 26-year-old female patient 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, 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 RASH MACULAR (Red spots on the entire both legs for almost 3 weeks). At the time of the report, RASH MACULAR (Red spots on the entire both legs for almost 3 weeks) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment was reported. No concomitant medication was reported.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.    This case was linked to MOD-2021-238755 (Patient Link).
She reports redness, warmth, and upper arm "soreness" in her left arm.  She reports the injection site was "a little red" after the injection and soreness didn't begin until Wednesday evening.  She says it's slowly improving, but the symptoms are not gone yet.
5 mins after initial shot, rapid heart rate that subdued in approximately 15 min.  About 12 hours after the shot, experienced swelling in face and closure of throat, excessive sweating, fatigue and disorientation/dizziness and muscle paralysis/weakness in the back of neck, needing to use my hand to lift my head up.
swelling, inflammation, erythema, firm skin area on lower 1/3 of rt humerus & upper 1/3 of radius/Ulna (forearm);pt able to flex & extend arm;
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 14-MAY-2017, the patient was vaccinated with an expired dose of RECOMBIVAX HB lot # K026531, expiration date 15-APR-2017, for prophylaxis (route of administration was not reported). No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
appetite loss; diarrhea; shoulder hurts; nausea; cold and not able to warm up; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (appetite loss), DIARRHOEA (diarrhea), ARTHRALGIA (shoulder hurts), NAUSEA (nausea) and CHILLS (cold and not able to warm up) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (blood pressure), Arthritis and Allergy to chemicals (Sulphur). Concomitant products included PARACETAMOL (TYLENOL) for Arthritis, AMLODIPINE for Hypertension.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced DECREASED APPETITE (appetite loss), DIARRHOEA (diarrhea), ARTHRALGIA (shoulder hurts), NAUSEA (nausea) and CHILLS (cold and not able to warm up). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (appetite loss), DIARRHOEA (diarrhea), ARTHRALGIA (shoulder hurts), NAUSEA (nausea) and CHILLS (cold and not able to warm up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included eye drops.
A 75 male patient, refer in the observation area a severed headache.  The paramedic take the vitals which were; BP; 170/100, PR: 90, temperature 96.9c, dextrose 97. At this moment we call the Dr. and she said observe  the patient for 30 minutes and put some ice in the forehead. When the 30 minutes finish we retake the vitals which were: BP;140/90, PR 66; temperature 96.9, RR 12.
Have never had a fever blister- until now; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Fl3248) via an unspecified route of administration in the right arm on 22Jan2021 at 10:30 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, ankylosing spondylitis and allergy to sulfa (sulfonamide allergy). 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 vaccination. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 24Apr2021 at 14:00, the patient experienced fever blister. The patient never had a fever blister until then. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. On an unknown date, the patient underwent antinuclear antibody (ANA)test and the result was positive. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fever blister was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
She is experiencing a metallic taste is her mouth for weeks; This is a spontaneous report received from a contactable consumer (reporting on herself). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number and Expiry date was not reported), via an unspecified route of administration in left arm on 19Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 for COVID-19 immunization. The patient reported that since Mar2021, was experiencing a metallic taste is her mouth for weeks and wants to know if it's going to go away or it is permanent. Side effects after your second shot may be more intense than the ones you experienced after your first shot. These side effects are normal signs that your body was building protection and should go away within a few days. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Headache, Myalgia, Arthralgia, NauseaVomiting, body aches, joint pain, nausea, headache
the vaccine is expired at time of vaccination; This spontaneous report was received from a registered nurse, referring to a 9 weeks old female patient.  There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-OCT-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# T040223, expiration date 12-JAN-2021; dose was not reported) orally for prophylaxis (Expired product administered).   This is one of two reports regarding the same patient.; Sender's Comments:  US-009507513-2110USA003436:
Pt was administered inactive flu vaccine on 9/18/17 lot # WT56808A exp: 6/30/17. Pt is 18.5wks pregnant at time of administration, with EDC: 2/14/18 by LMP. Pt doing well, did not have any side effects after administration. Pt will return to office in 1wk  9/25/2017 with Dr.
No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 05-JUN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection,  lot #W001518, expiration date: 13-JAN-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
Shingles developed on my left thigh a few days after the Moderna booster.  My initial vaccine was in March 2021 & it was Johnson & Johnson.  I had a mild case of shingles about 12 years ago, so I knew what it looked like/felt like.  This case was mild-moderate.
Elderly ES to inpatient MedSurg - Immunocompromised  No history of Evusheld per EMR Bivalent boost 10/2022
Patient with complaints of dizziness after shot was administered. Stated she was feeling well prior to shot (BP 128/97 prior to shot). BP 112/82 and 108/80 when nurse checked manual BP. Patient stated she felt better after being moved to another room, feet raised, BP taken, orange juice and bagel given. Patient remains A&Ox3, 122/80 at 10:25 AM. No complaints of dizziness. 10:50 AM patient stated she felt better with no complaints of dizziness or light-headedness.
Fever for 3 days, swollen body for about a week, and an outbreak of eczema that covered whole body and did not go away until food allergies were discovered.
Nothing after the vaccine, only the expected reaction, the injection site was a little sensitive (lasted 2-3 days). On 5/14 I woke up with achy joints like if you have a flu, I have a sore throat & major congestion, more than normal, I took the home test and it was negative, the next day I felt worst and it was negative again, but then after 20 minutes it was reddish, so I went to urgent care and did a rapid test and came Positive for COVID.
A nurse reported that a 34 year old female received an injection of Tetanus Toxoid Adsorbed, Ultrafined on 6/12/00. On 6/14/00, the pt developed a "low-grade" fever and generalized aches. She also developed an injection site reaction characterized by pain and swelling extending to her armpit. The pt recovered. Follow-up info received on 02/26/2001 from the physician indicated that the pt recovered by 06/16/2000 with "no lasting affects."