chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vaccine was expired on 03-OCT-2021, placed in the refrigerator on 03-NOV-2021 and administered on 05-NOV-2021; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (The vaccine was expired on 03-OCT-2021, placed in the refrigerator on 03-NOV-2021 and administered on 05-NOV-2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was expired on 03-OCT-2021, placed in the refrigerator on 03-NOV-2021 and administered on 05-NOV-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (The vaccine was expired on 03-OCT-2021, placed in the refrigerator on 03-NOV-2021 and administered on 05-NOV-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was placed in the refrigerator on 03-NOV-2021.Vial did not undergo any temperature excursion. No adverse event was reported.  No treatment medications were reported.
No adverse event; The patient received improperly stored VAQTA; Expired product administered; This spontaneous report was received from a certified medical assistant (CMA) and refers to a 2-year-old female patient. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications.  The CMA stated that on 26-NOV-2019, the patient was vaccinated with an improperly stored dose of Hepatitis A Vaccine, Inactivated (VAQTA) strength 25/0.5 (units not reported) (lot number S00952, with expiration date on 26-JUL-2020 but upon internal validation established as 05-MAY-2019) (dose, frequency, and route of administration and anatomical location were not reported) for prophylaxis.   The administered dose of the vaccine experienced a temperature excursion above 47 °F (52.09 °F) for 1.39 hours, as recorded by a data logger. The vaccine had a previous temperature excursion above 47 °F (64.83 °F) for 13.35 hours.  There was no adverse effect reported.
Tingling/numbness in left leg, moved up body to left arm, then went to other side of body.  Headache severe.  Heart palpitations.  Cramping in hands, trouble breathing lasted (3-4) days
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 5 (booster), single (Lot number: GJ2524) for covid-19 immunisation; BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Lot number: EN6205), on 28Mar2021 as dose 2, single (Lot number: ER8733), on 01Oct2021 as dose 3 (booster), single (Lot number: EW8733) and on 22Apr2022 as dose 4 (booster), single (Lot number: FL3198) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medications included: LEVOTHYROXINE, start date: Oct1990; NADOLOL, start date: Mar2022; ALENDRONATE, start date: Oct2018. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Jan2023) Positive, notes: still testing positive with flowflex rapid test on day 12. Therapeutic measures were taken as a result of covid-19, which included Paxlovid from 08Jan2023 to 06Jan2023. Clinical course: The patient had no known allergies. Despite mild symptoms to start, which were gone by day 4, the patient was still testing positive with flowflex rapid test on day 12, on 15Jan2023, which was recovering with no treatment.
Patient reported some pain, redness, warmth at injection site, slight head ache, some upset stomach with no vomiting.
terrible itching all over body, bad headache, bad chills, trouble breathing, panting, fear, disoriented, faint
2 patients received full dose Moderna Covid-19 vaccine when they should have received the booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (2 patients received full dose Moderna Covid-19 vaccine when they should have received the booster dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE NRVV AD26 (JNJ 78436735) in March 2021.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 05-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (2 patients received full dose Moderna Covid-19 vaccine when they should have received the booster dose). On 05-Nov-2021, ACCIDENTAL OVERDOSE (2 patients received full dose Moderna Covid-19 vaccine when they should have received the booster dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided. The patient has subsequently received a full 0.5 ml (100 mcg) as the Pharmacy thought they were receiving first dose in their Moderna COVID-19 series.
Few minutes after receiving Gardasil vaccine patient had vaso vagal type reaction, weak, dizzy, hot, sweaty. Felt like she was going to faint.
Reports that approximately 10 minutes after the vaccine administered began to have heart racing / palpitations and a metallic taste in the mouth. Very mild shortness of breath with the heart racing. After approximately 20 minutes symptoms resolved.
Shoulder swelled, was the circumference of a baseball. It also felt hard & warm to the touch.
arm swelling in same spot the injection was given, itchy, bright red, warm to the touch. continued for 3days
pain/3 other patients complained about the same issue; severe pain in my left ear/3 other patients complained about the same issue; This is a spontaneous report from a contactable consumer or other non hcp.     A patient of unspecified age and gender received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history were Breast cancer and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, the patient experienced pain/3 other patients complained about the same issue, severe pain in my left ear/3 other patients complained about the same issue on an unspecified date with outcome of unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021665582 Same reporter/drug/events, Different patient
Fatigue; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and MYALGIA (Muscle ache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced FATIGUE (Fatigue) and MYALGIA (Muscle ache). At the time of the report, FATIGUE (Fatigue) and MYALGIA (Muscle ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.  No treatment information reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient has positive COVID result on 07/08/2021 after having both Moderna vaccines. First one given 04/07/21, second dose given 05/05/2021
Information has been received from a consumer who is the mother of the patient, reported that her son went in for his 2 month immunization shots and he was suppose to receive the HIB vaccine (manufacturer unspecified by reporter) but the physician had given him hepatitis A virus vaccine. No AE involved. No further AE information provided. At this time, it was not reported if the patient sought medical attention. Additional information has been requested.
3/16/21 - Tightness down esophagus and into chest - lasted approx 5 hours.  Difficulty swallowing - continues to date.  Body and joint aches - at times unable to get out of bed - lasted the 21 days.  Rash on face -  first 48 hours then periodically throughout the 21 day,  Extreme fatigue,  tachycardia and palpitations - strong for the 21 days and continues to occur just not as often,   tinnitus,  dyspnea - 21 days and has not returned to normal.  Contacted dr, who ran bloodwork.  Bloodwork results - abnormal thyroid levels.  (had been stable for over 25 years).  Remaining under dr care.   4/8/21 - 2nd vaccine  Felt like I had the flu, sinus infection and tonsillitis all at once.  With Tylenol fever remained at 100.8 for 24 hours.  Symptoms lasted 72hours     After 72 hours felt healthy again minus they tachycardia, palpitations, difficulty swallowing and other thyroid symptoms
This spontaneous report was received from a 76 year old female consumer (reporting on herself) with no pertinent medical history. In July 2011 the patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) (dose and route not reported). Concomitant therapies included Hydrocodin and gabapentin. In January 2013 the patient experienced a sensation going along her breast to her back, she thought it was a pulled muscle. However a few days later she started to feel a burning sensation on her skin. She felt nerve damage under her right breast traveling to her lower back (a piercing sensation). No blisters or itching on her skin just the "burning" patient did not sought medical attention and an unspecified treatment was given. Laboratory diagnostic studies included CT scan, X-ray and blood work (results not reported). At the time of the report the patient's outcome was unknown. Additional information has been requested.
06/09/20 heart palpitations; dizziness; This is a spontaneous report from a contactable Other HCP (patient). A 30-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Ek5730), via an unspecified route of administration in right arm on 06Jan2021 at 2nd single dose for COVID-19 immunization. Medical history included hoshimotos. No Covid prior vaccination. No known allergies. Historical vaccine included BNT162B2 on 16Dec2020 (1st dose) for COVID-19 immunization. Concomitant medication included levothyroxine, bupropion, desvenlafaxine succinate (PRISTIQ), topiramate (TOPIMAX). No other vaccine was received in four weeks. The patient experienced 06/09/20 heart palpitations and dizziness, both on 09Jan2021 11:15 with outcome of unknown. No Covid tested post vaccination.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 41 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Tree nuts" (unspecified if ongoing), notes: Known allergies: Tree nuts. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Jul2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Treatment of COVID-19; (unspecified date) Negative, notes: I tested negative when treatment ended,; (17Jul2022) Positive, notes: positive again 6 days later. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti viral treatment with Paxlovid received from 06Jul2022 to 11Jul2022 for covid-19.   No follow-up attempts are possible. No further information is expected.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 81-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Jan2021 10:15 (Lot number: E13246) at the age of 81 years as 1st dose, single and administered in arm right, administration date 29Jan2021 (Lot number: E19262) as 2nd dose, single for covid-19 immunisation. Relevant medical history included: "High Blood Pressure" (ongoing), notes: Verbatim: High Blood Pressure /diagnosed when she was 21; "Diabetes" (ongoing), notes: Verbatim: Diabetes /diagnosed about 5 years ago; "sulfa drugs that's all, makes her nauseous" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Flu shot, administration date: Oct2020, for Immunisation.The following information was reported: Nausea, No appetite, Vomited with outcome of recovering, unknown, Feeling unwell, Weakness with outcome unknown, Bout of diarrhoea, Dehydration with outcome of recovered and all described as "She had the dry heaves and was gagging". The events "nausea", "feeling unwell" and "bout of diarrhoea" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nausea, vomiting. No follow-up attempts are possible. No further information is expected.
started APAP p/vax on 9NOV; no problems that day; 10NOV @ noon started crying (painful cry) inconsolable til 8PM, vomited-given APAP; slept 8PM to next AM  & awoke feeling well; had local tenderness-unsure if rt or lt thigh;
Flu shot was done at a flu clinic. Patient experienced shaking, difficulty in breathing, hoarseness of voice, wheezing, uneasy. One of the doctors in the clinic gave her oral Benadryl and administered Epipen. 911 was called.
Pneumonia shot given in right arm on 10/28/2005. By evening I was unable to lift my arm more than 6" from body. Large red line under swelling, Welt increased in size on Saturday but mobility improved. Welt still red and larger but good mobility by Sunday. Monday less swelling and redness and soreness. Tuesday just slight discoloration, strength also affected.
It was reported that a 23 month old male received TriHIBit (Tripedia and ActHIB combined) on 11/30/99. Reportedly, the pt had complaints of cellulitis beginning on 12/1/99. There is no additional information at this time. From additional correspondence received on 2/3/00, it was reported that the pt recovered from this experience. Additional pt and responsible physician information was also provided.
pt recvd vax 31AUG93 & on 2SEP92 devel swollen lymph glands on the rt side of neck but had no fever; 6SEP92 t99, achy joints, ulcers in throat & mouth; seen by MD;
Pt states she came to facility and received 2 shots on 10/05/2009. Records show MMR and Tdap was administered. She states immediately developed pain right lower quadrant and lower abdomen. Denies nausea, vomiting, rash. Symptoms lasted 2 days. States on 10/11/2009 "body became light". Non specific in complaint or description. States on Tues 10/13/2009 prior to returning to facility "feel funny in my body" Non descriptive in definition. Has not been seen by HCP.
Mass of small intestine - Procedures: laparoscopic removal of gastric band with open ileocolic resection and bilateral salpingectomy and oophorectomy. Recovery in hospital. Hospital admission within 6 weeks of receiving the COVID vaccine.
Same day - 2 hr later - began to feel like I had shingles by 10 hrs after my arm ached like full-blown shingles. Next day arm improved but visual problems and legs collapsed from under me. Was away x 3 more days and it happened again (vision/weakness)
chills; headache/ head hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 71-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 04Oct2023, outcome "unknown"; HEADACHE (non-serious) with onset 04Oct2023, outcome "unknown", described as "headache/ head hurts". Additional information: Patient could not remember if she was advised to take paracetamol (TYLENOL). She was asking if it's okay to take paracetamol after receiving the vaccine as she did not want to minimize the effect of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt arrived with shortness of breath and cough.  Pt has PMH of CKD stage III and is status post renal transplant, heart failure preserved EF, and type II DM.  He has been having these symptoms along with body aches and weakness for 8 days.  He is chronically immunosuppressed on antirejection medications for renal transplant.  He was admitted for pneumonia due to COVID -19 virus.
Information has been received from a physician concerning an approximately 15 year old female patient who on 15-AUG-2009, was vaccinated with the first dose of GARDASIL (Lot # 660620/0571X). On 15-OCT-2008, the patient was vaccinated with the second dose of GARDASIL (Lot # 660557/0072X). On 21-JAN-2009, the patient was vaccinated with the third dose of GARDASIL
the patient was afraid of needles and blood, the patient was given the shot and asked to remain sited in front of the pharmacy, but in few minutes he got up, got dizzy and fall down, he had never lost consciousness
On an unspecified date, the pt received an injection of Lymerix and some time later, the pt developed severe swelling in the arm, hand and shoulder (same arm that the injection was given). As of 8/29/00, the outcome is unknown.  Follow up on 02/02/2001: "Shoulder swelling in a 78 year old female prescribed Lymerix.  This report was received from a physician via a sales representative.  Follow up information was received from the physician.  The patient was taking no concurrent medications.  Concurrent medical conditions included degenerative joint disease (since the 1980's).  On an unspecified date, the patient received an injection of Lymerix (dose and series number not specified).  On 06/24/2000 the patient developed severe swelling in the arm, hand, and shoulder in the same arm that the injection was given.  The physician felt the symptoms were related to Lymerix.  Information received on 11/03/2000 reported that the events resolved.  The event of "swelling in shoulder" does not meet ICN serious criteria but is being submitted as an expedited report by special request per the 06/28/2000 letter.  The initial section of this report was submitted on 09/07/2000.
This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported. On 16-JAN-2015, the patient was vaccinated with an improperly stored dose of VAQTA lot # K018525 and expiration date: 28-APR-2017 (Route was not provided). It was stated that the excursion duration was 12 hours and the highest temperature recorded was 46.6 degrees F (8.1111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
>35 days from first dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days from first dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days from first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days from first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications are provided. treatment to the events not reported. patient has  not yet received a second dose due to personal reasons.
The patient reports that he developed erythema at the antecubital fossa of his right and left arms 1 hour after administration of the vaccines. The patients reports that several hours later he developed blisters and burning at the antecubital fossa of his right and left arms. The patients reports some mild itching but mostly burning. The patient reports that the blistering and burning lasted for several days. The patient reports that the rash is resolving. On exam 6 days later the patient has hyperpigmentation and slight erythema of the affected area.
Chronic Fatigue/Narcolepsy 6+ Years. Muscle weakness 6+ years. Memory loss/confusion 6+ years. Chronic joint and back pain 6+ years. Vision problems 5+ years. Trouble concentrating 6+ years.
Within 3 hours of vaccination, mother states her daughter could not feel her legs from knees down - numb. By 24h after vaccination, numbness subsiding but still tingling. By Monday (9-28-15), resolved.
After the COVID vaccine, it started numbness in hand fingers while sleeping, slowly, slowly and day by day it become more. Last four days I could not able to sleep, whole body getting numb while sleeping, and it getting all blood to the hands, legs and hand figures, foot fingers are becoming numb.   And also getting pains in the bone joints, specially in fingers. Getting Itchy, eye pain due to no sleep. Some one should call and provide remedy immediately, otherwise I may die, this responsible is control organization. This I am entering at May 4th 2:00AM CST.  I already registered online, no responded.
She was inadvertently given 2nd dose of Moderna vaccine from a vial that had reached its beyond use date 10 days prior.   She denied any adverse effects or side effects from the vaccine administered.