chrisvoncsefalvay/vaers-outcomes huggingface dataset:
We administered 1 dose of Moderna Covid-19 bivalent 2 days after BUD.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We administered 1 dose of Moderna Covid-19 bivalent 2 days after BUD.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (We administered 1 dose of Moderna Covid-19 bivalent 2 days after BUD.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We administered 1 dose of Moderna Covid-19 bivalent 2 days after BUD.) 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 EXPIRED PRODUCT ADMINISTERED (We administered 1 dose of Moderna Covid-19 bivalent 2 days after BUD.).    No concomitant medication was reported.    Patient received Additional Booster dose. No treatment information was reported.
Nursing facility, patient, and patient's family stated this was patient's first dose of the Covid vaccine. Vaccine was administered without any issues, however upon entering vaccine into patient's IMPACTSIIS profile, it was discovered that patient had already received 2 doses of the Pfizer Covid vaccine in March of 2021. Due to the fact that this was not known prior to the patient being administered a Moderna vaccine , patient has now been given 3 total Covid vaccines. Nursing facility was contacted made aware of the situation. Patient will now be monitored by a physician for any adverse effects of the Moderna vaccine and a 2nd Moderna vaccine will not be administered.
Over 36 hours after shots, baby is still extremely fussy, had trouble sleeping, vomiting, and waking with nightmares.
pt did check the box saying she has a seizure disorder. However, pt stated that she was due to for one per her drs recommendation and that she has had it before in the past with no issues. Pt did lose consciousness + had a seizure for at lesat 30 seconds. The pt's partner was there to assist and he was able to get her out of the seizure. I did call EMS but the pt declined emergency care. I had the pt stay for monitoring and gave her some water. Pt left of her own free will with her husband. I did call her at the end of my shift just to make sure she was ok and it seems she is doing fine and will follow up with her neurologist
Patient received vaccine on 4/26/21 and had mild fatigue and malaise, otherwise in his usual state of health.  On 4/30/21 he was working in his barn and towards the end of his work he began to feel some palpitations and chest tightness.  This did not go away despite resting causing him to come to the emergency department. No known history of cardiac arrhythmia, does not follow with cardiologist.  No recent travel.  No significant alcohol use.  No new medications.  No unusual events over the last few days. Found to have new-onset atrial fibrillation on EKG. He was given diltiazem to reduce rate.
A report has been received from a Health Professional concerning a male patient, who had been receiving Nasal FLUMIST QUADRIVALENT, 0.1mL, in each nostril. FLUMIST QUADRIVALENT was started on an unknown date. It was reported that twins received expired FLUMIST on 27-Jan-2016 that expired on 20-Jan-2016. The outcome of the event of given expired medication was unknown. The reporter's description of the event(s) was as follows: No pertinent medical history reported. The report was considered to be non-serious.
Narrative:  Patient was diagnosed with pancytopenia and was hospitalized from July 20, 2021 to present. He has no history of diagnosis of anemia until after COVID vaccines. He had reported foot pain, SOB and fatigue since April 6, 2021.
Abdominal cramping, abdominal pain, and headache for 3 days then naturally resolved. Given fluad instead of flulaval.
Per vaccinator, while administering vaccination the needle retracted prematurely and the vaccine sprayed out. More than half the dose was not administered to patient. A replacement dose was given.   Syringe/needle was Vanishpoint brand.
I was given the shot on 9-12-17 with no issues. I was then given the shot again on 3-30-18 and an hour after I felt dizzy, severe headache and my arm where I was given the shot was red and numb. I had diarrhea and was nauseous.
COVID Booster given 05 Oct. Second Rabies booster given October 6th in same arm. Soreness and weakness has persisted in joint for weeks and was not improving quickly. No swelling just pain, inflammation, and difficulty lifting and moving things with left elbow. Given methyl prednisone shot followed by standard taper which is finishes tomorrow 02-Nov. Still experiencing some pain, but there is improvement. (These dates are correct) if I put the wrong dates earlier in the form.
No adverse effects; The patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date since 22-APR-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R017768, expiration date: 21-JUN-2020 (dose, frequency and anatomical location were not provided), administered subcutaneously as prophylaxis. The vaccine underwent a temperature excursion from -9 Celsius degrees (°C) to 8°C (-7.4C) during a time frame of 55 minutes as recorded by digital data logger. No previous temperature excursion was reported as well as no adverse effects. The sterile diluent used to reconstitute the vaccine (lot # S000130, expiration date: 21-JUN-2020) was properly stored.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-1905USA005506: US-009507513-1905USA005505: US-009507513-1905USA005488: US-009507513-1905USA005507: US-009507513-1905USA005503:
Herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning an elderly male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2014, at approximately age 66, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a physician for the following injury resulting from his zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
Two weeks after receiving the final injection, my father was admitted to the hospital with pneumonia. He had poor oxygen saturation which prompted a visit to the ER. Upon x-ray he was found to have a large pneumonia in his left lung. After 10 days at the local hospital,  and being placed on a ventilator, he became septic and was air lifted to one of our area's larger hospitals. There, he was diagnosed with necrotizing pneumonia caused by pseudomonas aeruginosa. He also had heart rate accelerations that would climb into the 150s and they could never figure out why. He was treated aggressively with antibiotics and was successfully weaned off the vent. However, his body was unable to fight off the infection and he ended up passing away from necrotizing pneumonia that caused his respiratory system to fail. My father had underlying COPD that was well-managed at home and he did not require oxygen. I was questioned several times as to whether he'd gotten into or been around anyone or anything different from his usual, but he had not. The only thing out of the ordinary he had was the Moderna injections.
3 days after administration patient developed cellulitis with 12x16 cm erythema, tenderness, warmth. MENACTRA and VARIVAX administered. Same leg.
Pt initially seen for physical exam on 12/12/01. The physical was wnl except for dental caries, a referral was made to dentist, and a diagnosis of Scabies. The family was given scabies education. A Hct/Hgb, with 99.5 NAAC, urine/UC, vision screen, hearing screen and PPD (all negative results) MMR, HBV and HAV given on 1/4/02.
The pt presented to the health center 24 hours post vax with a fever of 100.6 and hives on the face, extremities and trunk of body.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information was provided by the reporter.
Next morning - limited arm movement, swollen arm down to elbow, warm to touch, red blotchy rash
cloudy head experience made it hard for the patient to focus; cloudy head experience made it hard for the patient to focus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1), for COVID-19 immunisation. The following information was reported: FEELING ABNORMAL (non-serious), DISTURBANCE IN ATTENTION (non-serious) all with onset 07Apr2021, outcome "unknown" and all described as "cloudy head experience made it hard for the patient to focus".  Additional information: The events were reported as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Site: Pain at Injection Site-Severe, Error: Wrong Dose of Vaccine - Too High, Additional Details: Patient states her covid vaccine was administered too high and hit a nerve causing pain.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 11-JAN-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, lot number L040415, expiration date 13-APR-2017 (dose, route and anatomical location were not reported) for prophylaxis (incorrect product storage). The vaccine was exposed to temperature of -5 Fahrenheit (F) (-20 Celsius(C)) and to the lowest recorded temperature of -14 F (-25C) during 4 hours and 5 minutes. The storage type was reported as "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA012890: US-009507513-1701USA013083: US-009507513-1701USA013084: US-009507513-1701USA013085: US-009507513-1701USA013086: US-009507513-1701USA013087: US-009507513-1701USA013088: US-009507513-1701USA013089: US-009507513-1701USA013090: US-009507513-1701USA013091: US-009507513-1701USA013093: US-009507513-1701USA013094: US-009507513-1701USA013095: US-009507513-1701USA013096: US-009507513-1701USA013097: US-009507513-1701USA013098: US-009507513-1701USA013099: US-009507513-1701USA013100: US-009507513-1701USA013101: US-009507513-1701USA013102: US-009507513-1701USA013103: US-009507513-1701USA013104: US-009507513-1701USA013105: US-009507513-1701USA013106:  US-009507513-1701USA013107: US-009507513-1701USA013108: US-009507513-1701USA013109: US-009507513-1701USA013110: US-009507513-1701USA013082:
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-JUL-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # J005706, expiration date 15-AUG-2015 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 51 degrees Fahrenheit for 15  hours. There were no previous excursions reported. Data logger: unspecified. Lot number J005706 is an invalid lot number for M-M-R II. This is one of several reports received from the same reporter. Additional information is not expected because there was no consent to contact healthcare worker.
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 medical history, concurrent conditions, or concomitant medications. On or about 05-JAN-2017, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not specified) for its intended purpose: the prevention of shingles. On or about 04-NOV-2017, the patient experienced complete hearing loss in her left ear. On or about 05-NOV-2017, the patient continued to experience hearing loss in her left ear and felt disoriented so she went to an emergency room, where a computerized tomography (CT) scan was done (results not specified). On or about 28-NOV-2017, the patient continued to experience hearing loss in her left ear.  She had a magnetic resonance imaging (MRI) done (results not specified). On or about 29-NOV-2017, the patient was tested for hearing loss by a physician of an Ear Nose and Throat Surgery center, who documented hearing loss in the patient's left ear. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of The Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events were not resolved.  Causality assessment was related. The events complete hearing loss in her left ear and feeling disoriented were considered disabling. Upon internal review, the event of complete hearing loss in her left ear was considered to be medically significant.
24 hours post vax, the pt developed swelling, hardness, redness, and pain at injection site. He also experienced chills/sweats.
Felt lightheaded "woozy) approximately for 10 minutes after vaccination. Ambulated to healthcare, he is fasting for religious. No food or water taken. He felts better. Ambulates normally. Discharged at 09: 26 AM
Patient did not remember having  previously been vaccinated with shingrix on 8/1/2018 and 11/1/2019.
Stroke involving paralysis of right arm, right leg, slurred speech, facial droop, nausea, garbled speech
patient became unconscious approximately 15 minutes after receiving vaccine .  called 911 for assistance.  administered epi-pen into left thigh of patient.  patient slowly became conscious with paramedics monitoring  vital signs
muscle pain primarily in my legs; This case was reported by a consumer via (Shingrix GSK and described the occurrence of myalgia of lower extremities in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2021, the patient received Shingrix. In September 2021, less than a week after receiving Shingrix, the patient experienced myalgia of lower extremities. On an unknown date, the outcome of the myalgia of lower extremities was not recovered/not resolved.   It was unknown if the reporter considered the myalgia of lower extremities to be related to Shingrix.  Additional details were provided as follows: The patient self reported this case. Age at vaccination was not reported. The patient received dose of Shingrix vaccine and have had muscle pain primarily in his/her legs since getting the shingles vaccine (4 days ago). The reporter wanted to know how long could he/she expected this to last. The follow-up would not possible as no contact details were available.
2 cm redness at site, then dry/flaky.  No c/o pain or itching
2 month shots given 8/18/06. Developed a fever up to 101. 8 after shots and into Day 2. Playful but increased sleep. No other s/s.
The symptoms started the following day. Itching, redness, swelling and heat. The swelling kept spreading. Called doctor's office and doctor recommended Benadryl and compresses. Three days later, went to ER and was told that I had a severe allergic reaction. Prescribed Prednisone. Swelling had moved to lower arm.
This case was reported by a healthcare professional via sales representative and described the occurrence of swelling arm in a subject of unspecified age and gender who was vaccinated with KINRIX. On an unspecified date, the subject received unspecified dose of KINRIX. At an unspecified time after vaccination with KINRIX, the subject experienced swelling arm, discomfort and injection site redness. On 11 November 2008, the sales representative was contacted by the healthcare professional office that completed a Vaccine Adverse Event Report and inquired where to send
Case number PHEH2014US003667 is an initial spontaneous report from the consumer received on 21 FEB 2014. This report refers to a 17-year-old male patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) at a dose of 0.5 ml intramuscularly on an unknown date in JAN 2014. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Hospitalized on 03/07/023 with severe SOB, remains on oxygen in hospital.
Extremely sore arm, Fatigue, and general malaise, low grade fever (started day after injection, lasted 3-4 days after immunization) Tonic-clonic seizure on Wednesday 11/7/2019 Symptoms- aura, visual disturbance (bright spots intensified until loss of consciousness), felt body tense up, low moan, and felt clonic full body shaking before losing consciousness. Was able to lay down because I felt like I was losing consciousness. Have a blank of around 45 minutes. In which time I moved from living room floor to bed without any recollection of the movement. Came to with all my muscles in my body very sore and a throbbing headache focalized in occipital region of my head. Very confused during post-ictal period. Confusion and soreness lasted throughout the rest of the day. Finally felt a sense of normalcy after a night?s rest.
pt recv vax & devel redness @ inj site which persisted for @ least 4-5 days;pt recovered;
Pain in left arm; Fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 33-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 29Mar2021 at 09:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 09Mar2021 at 14:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 19:00 the patient experienced pain in left arm and fatigue. The clinical outcomes of the events pain in left arm and fatigue were unknown at the time of reporting.   No follow-up attempts are needed. No further information is expected.
5 min after admin. of vaccines pt presented with urticaria on lower extrem, chest clear. Pt was comfortable, resolved with treatment, observed in office x 15 min.