chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature excursion that had occurred in a refrigerator; No Adverse Event; temperature excursions have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (temperature excursions have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that had occurred in a refrigerator) and NO ADVERSE EVENT (No Adverse Event) in a 57-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     It was unknown if the patient ever been diagnosed with/ tested positive for COVID-19.     On 23-Sep-2022 at 10:42 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 23-Sep-2022 at 10:42 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (temperature excursions have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that had occurred in a refrigerator) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (temperature excursions have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that had occurred in a refrigerator) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (temperature excursions have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that had occurred in a refrigerator).    Concomitant medication was not reported.  It was unknown if the patient had ever tested or been diagnosed with COVID-19.  The patient received 3 primary doses of Moderna vaccine intramuscular in deltoid.  Vaccine 4th dose reported as 0.5 in Deltoid muscle. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. The Moderna and Bivalent vaccines have undergone several temperature excursions and may have been administered to patients.   Treatment drug was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654158 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654158:
This spontaneous report was received from a register nurse referring to multiple unspecified patients of unknown genders and ages. The patient's medical history and concurrent conditions were not provided. On an unknown date in November 2015, the patients were vaccinated with an improperly stored doses of (Oka/Merck) VARIVAX lot # L025207, expiration date 07-JUL-2017, and lot # L020004, expiration date 02-JUN-2017, (route, anatomical place and dose number were not provided), indicated for prophylaxis. Concomitant therapies were not provided. At the time of the report, no effects were reported. This is one of several reports received from the same source. Additional information has been requested.
FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. 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) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 04-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
In 12/98, the pt developed varicella and sought unspecified medical attention. No further information is available.
On Saturday 3/20/21, Patient developed a circular rash below injection site on left arm.  She had swelling and pain from left shoulder to elbow and radiating pain up to neck and down to hand with numbness in hand.  Patient said the rash lasted about 2-3 days.  On 3/27/21, Patient went to ER due to pain and was given naproxen.  She went back to ER on 3/29/21 due to continuing to have pain. She is to follow up with PCP this week.
Migraine 14 hours following shot. And lasted 12 hours. Medication did not help.
Rash over face and trunk almost immediately following immunization. ER was called for Benadryl dose and child was given 4ml of Benadryl 12.5mg per tsp. Appointment made for child at clinic, attended, was told to continue Benadryl.
received only the liquid CWY component of Menveo; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA957A, expiry date 30-SEP-2024) for prophylaxis.   On 29-AUG-2023, the patient received Menveo. On 29-AUG-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: received only the liquid CWY component of Menveo) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 30-Aug-2023 The patient had been given only the grey top vial (Liquid Conjugate Component) of Menveo. A nurse reported that a patient received only the liquid CWY component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The health acre professional (HCP) consented to follow up via email; Sender's Comments:  US-GSK-US2023118684:same reporter US-GSK-US2023118682:same reporter US-GSK-US2023118666:same reporter US-GSK-US2023118665:same reporter
Shortness of breath, sinus swelling, swelling in face, minor irritation of throat, warm, red skin on face and neck, dizziness  Onset roughly an hour after injection, slow, progressive intensity of symptoms until roughly 11:30pm, at which point arrived at Emergency Department  Treated with benadryl and prednisone in ED. At about 10:30am the following day, breathing clear and even,, no swelling or irritation in face or throat, some lingering redness and heat in face, second dose of prednisone administered at ~11:30am, symptoms continued subsiding.
Chills; Arm Soreness; Malaise; sore throat; warm body feeling; This is a spontaneous report from a non-contactable consumer. A 35-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) on her right arm, via an unspecified route of administration on 04Feb2021 13:30 at a single dose for covid-19 immunization. Medical history included thyroid condition and environmental allergies. Concomitant medication included cetirizine hydrochloride (ZYRTEC) and levothyroxine. The patient experienced Chills, Arm Soreness, Malaise, slight sore throat, warm body feeling; all for 05Feb2021 10:00AM. No treatment was received for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
This is a 86y.o. female with significant past medical history of HTN, T2DM, COPD, OA, pAfib, hyperlipidemia, and lung CA S/P resection  that presented to the hospital with chief complaint of shortness of breath. She states for the past 1 week she has had worsening shortness of breath. She went to her PCP whom prescribed her oral Prednisone and Doxycycline. Her symptoms have not improved. She was noted by family to have severe dyspnea on exertion and EMS was phoned. Patient was reluctant to come to the ED. She was found on their arrival to be hypoxic with SPO2 in the 80s. She admits to non productive cough. She denies any fever, chills, chest pain, palpitations,  abdominal pain, nausea, vomiting, diarrhea, constipation, or urinary complaints.    In the ED, patient normotensive, afebrile, stable SPO2 on NRB mask. COVID detected. Elevated acute phase level reactants. Procal 0.28. D-dimer 1829. CXR with multilobar pneumonia. She has been admitted for further evaluation and management with ID and pulmonology consultations.    Patient seen and examined only by the attending physician. NP only responsible for chart review in an effort to limit exposure given the patient's COVID positive status.
Information has been received from a physician concerning an approximately 29 year old female who was vaccinated with a dose of MMRII as a child. On 09/28/01, a premarital titer were equivocal for mumps. The physician also reported that the patient's boyfriend also experienced lack of responses after receiving vaccination with MMRII. (see WAES01100175). No further information is available.
pt c/o slight headache, distorted vision, nausea, elevated heart rate,  pallor and sweating. symptoms appeared and went away in a duration of about  5 minutes.
Nauseous; Emesis/threw up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 21 year-old female patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (Lot number: EN6199) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "not recovered", described as "Nauseous"; VOMITING (non-serious), outcome "unknown", described as "Emesis/threw up".  Additional information: Reporter stated, "Her daughter got the vaccine on Saturday. And yesterday, she woke up and was nauseous and threw up. And today, she was also nauseous. And she want to know if that was a normal reaction?".  No follow-up attempts are possible. No further information is expected.
Approximately one week after receiving zoster vaccine, patient developed a mild band like rash approx T8-T10 on left flank, with significant discomfort that lasted for approximately one week and then resolved spontaneously.
Patient received VZV immunization on 10/21/08.  On 11/17/08 small papules began to appear over legs, arms, and trunk.  Fever onset on 11/18/08 at home (97.8 temperature here today). Patient has 50 or less scattered lesions.  (Mom states that years ago, two siblings both developed rash after receiving VZV immunization #1, children now age 9 and 12).
within 10 minutes of getting vaccine she developed, sweaty, lightheaded, developed headache. Both hands started tingling. These sx started to go away, but then later in the day she developed sores on the  roof of her mouth. The next day she developed dizziness and headache. She then developed hives on her tongue and head/body itchy.   Her entire body feels swollen.
fatigue; low grade fever; incredible body ache; rash/looks like measles on her face; first dose 22Dec2020, second dose 15Jan2021; first dose 22Dec2020, second dose 15Jan2021; This is a spontaneous report from a contactable healthcare professional reporting for self. This 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284) on 15Jan2021 at single dose for COVID-19 immunization. Medical history was none. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS). The patient previously received first dose of BNT162B2 (lot number: EL0140) on 22Dec2020 at single dose for COVID-19 immunization, and experienced fatigue, low grade fever and rash. The patient received the vaccine and had minor side effects that were explained like fatigue, low grade fever, everything responded to the ibuprofen (ADVIL) a NSAID. The booster received on time on 15Jan2021 and she had a quite a challenge with it for about a week, she had the increased fatigue, really incredible body ache, the fever went away in about 2 days but fatigue lasted definitely a full week. About the 3rd day a rash started and that was not going away, she was not sure what to so about it, it became worst if she exercise, very prominent if she exercise. It's been a little over a week with symptoms of fatigue and body ache went away. The rash that she can not get rid of; It was very disturbing the rash; looks like measles on her face. Treatment included the body ache was responding to ibuprofen but fatigue she just trying to take more rest. Lab data included CBC (Full blood count) on unspecified date, that was normal. The outcome of fatigue, low grade fever, incredible body ache was recovered on unspecified date, outcome of other events was not recovered. Causality assessment from the reporter between the vaccine and events was related.
Within 20 min of receiving the injection, my upper lip was tingling and swelling slightly.  Within an hour, the left side of my face was numb back to behind my left ear. My eardrum was tingling also. I had slight swelling on my face and tightness of my cheek muscle. I never felt any tingling or numbness in my throat or tongue. It took about 36 hours for it to completely go away.
FELL; GAIN WEIGHT; This spontaneous report received from a consumer concerned a 35 year old male. The patient's height, and weight were not reported. The patient's past medical history included: chipped bone thumb, gall stone, gall bladder removed, and pain, and concurrent conditions included: depression, anxiety, shaking, urinary urgency, and multiple sclerosis and other pre-existing medical conditions included: The patient was on store brand multivitamins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included clonazepam, cyanocobalamin, ergocalciferol, escitalopram, fish oil, naproxen sodium, ocrelizumab, oxybutynin. On an unspecified date, the patient experienced fell, and gain weight. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fell and gain weight was not reported. This report was non-serious.
tenderness on the left arm where she received the vaccine dose.; severe pain in right shoulder joint and right hip joint/It was so severe she could hardly get out of bed; Headache; This is a spontaneous report from a contactable nurse (patient). A 71-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EJ1686, expiration date unspecified), via an unspecified route of administration on 31Dec2020 11:00 at single dose (left arm) for COVID-19 immunization. Medical history included arm soreness from flu shot 2-3 months ago. There were no concomitant medications. It was reported that she received her 1st dose of the vaccine on her left arm on 31Dec2020 as she works with elderly at nursing home and she was of age. Two days after her shot, on 02Jan2021, she experienced little headache which lasted all day but was gone by the following day. On 12Jan2021, 2 days ago, when she woke up and got of bed with severe pain in right shoulder joint and right hip joint which lasted for maybe 10 minutes. It was so severe she could hardly get out of bed. Currently, she had no joint pain. The right shoulder and right hip pain were so odd she thought, but it has also improved since. It's been 2 weeks and she never had this happen before. This lasted a little while, but thought it was from the cold weather since it's been 2 weeks since having the vaccine. She still has a bit of tenderness on the left arm where she received the vaccine dose on an unspecified date. She mentioned this to her supervisor and was encouraged to call and she wants to know if this could be a side effect. The patient had no vaccines the same day or 4 weeks prior. She had the flu shot before in past and the area would be sore for a few days, but now with this Covid vaccine this arm was still tender. Also, she had gotten the shingles shot the same day as the flu shot but that was about 2-3 months ago, at least 2 months ago. The patient had no additional vaccines administered on same date of the Covid vaccine. The patient had no prior vaccinations within 4 weeks prior to the first administration. Outcome of event headache was recovered on 03Jan2021; severe pain in right shoulder joint and right hip joint/it was so severe she could hardly get out of bed was recovered in Jan2021; and outcome of tenderness on the left arm where she received the vaccine dose was not recovered.
This spontaneous report was received from a registered nurse, refers to an unknown number of patients, of an unknown age and gender. Medical history and concurrent conditions were not reported. The register nurse informed that on an unknown date, the patients were vaccinated with MMR II (strength, dosage, route, lot# and expiration date were not reported). That had been improperly stored. No adverse effects were reported. This is one of several case received from the same reporter. Additional information is not expected because the physician refused to be contacted.
Pt. was administer 0.1 ml of what was assumed was Aplisol TB vaccine, but realized after inj. that it was the polio vaccine, which had been stored in refrigerator where Aplisol is stored, not polio. Per manufacturer, ACIP states No reported risks exist R/T this
deltoid muscle very sore & red to begin w/swelling got inc worse & a red area appeared & has become enlarged to 2 1/2in across;pt did run fever of 102 x 1 days;pt was taken to PMD;no tx required;lt arm swollen, red & itching 7cm x 5cm circu
Mild swelling approximately 1.5x1.5 with light redness to right bicep area. Reaction was reported to our clinic on 3/9/18.  Ice applied x20min. with instructions to continue ice at home. Acetaminophen 650mg po given and Ibuprofen 400mg given. On 3/12/18 employee returned to clinic and was given Loradamed and a Prednisone dose pack.
Caller had vaccine at 2:30 pm today.  Vaccine given in left arm.  Now states he has quarter size swelling on his left side of his face starting from his left eye to his mouth with redness and itching.  Advised to call his PCP.  24 follow up will be done.
pt recv vax 10AUG98 & mom reported pt had temp >101 w/in 3hr p/vax;10AUG98 lt arm had redness & swelling from shoulder to elbow;
Pain/aching on the left side of  face; head/hair pain; lymph nodes pain; felt like  had sinus congestion or was bruised; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: EP7533) via an unspecified route of administration in the left arm on 08Apr2021 at 10:30 AM (at the age of 39-year-old) as a single dose for COVID-19 immunisation. The medical history of the patient included none. The concomitant medications was not reported. The patient had no known food allergies (NKFA). The patient did not receive any other vaccines within four weeks prior to the vaccination Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 09Apr2021 at 21:00, next day of vaccination, the patient experienced pain/aching on the left side of the face, head/hair, lymph nodes,  hair follicles hurt, face felt like sinus congestion or was bruised, sharp feeling with  would swallow. The patient did not receive any treatment for the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 12Apr2021, the patient underwent Nasal Swab and the result was negative and also PCR test and the result was Negative. The clinical outcomes of the events pain/aching on the left side of face, head/hair pain, lymph nodes pain and felt like sinus congestion or was bruised were recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
injection site leaking black stuff; arm not healed; Scald; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCHARGE (injection site leaking black stuff), IMPAIRED HEALING (arm not healed) and THERMAL BURN (Scald) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054G21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCHARGE (injection site leaking black stuff), IMPAIRED HEALING (arm not healed) and THERMAL BURN (Scald). At the time of the report, VACCINATION SITE DISCHARGE (injection site leaking black stuff), IMPAIRED HEALING (arm not healed) and THERMAL BURN (Scald) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Left armpit hurts; feels like a golfball size knot; This is a spontaneous report from a contactable other health care professional, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 27Mar2021 at 12:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had allergy to sulfa drugs. Concomitant medication included sertraline (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021 at 07:00, the patient experienced left armpit hurts and felt like a golf ball size knot. The patient did not receive any treatment for the reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events armpit hurts and felt like a golf ball size knot were not recovered at the time of this report.  Information about lot/batch number cannot be obtained; No follow-up attempts are needed;
Twelve days after receiving vaccine, patient developed a rash on his face that spread from one cheek over the ear and the neck. It was red, itchy, crusty and oozing with pus.  Four days later he saw the doctor and was prescribed Mupirocin Ointment, as it was considered a staph infection. His rash cleared up, on his face, but spread to his eye by 10 days later. Eye became inflamed, pink, itchy, with discharge. He was prescribed Cephalexin orally and Moxifloxacin eye drops to address it.  After 4 days, rash subsided.