chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No further AE; MMRII and PROQUAD look too similiar; Wrong vaccine administered; Medical assistant calls to report PROQUAD w026326 2/18/2024 and VARIVAX x010535 4/11/2025 administered to a  12 month old patient on the same day.  No further AE.  request  02506115.  No PQC; This spontaneous report was received from a medical assistant and refers to a 12-month-old.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-NOV-2023, the patient was vaccinted with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, one time, lot #W026326, expiration date: 18-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided); and  varicella virus vaccine live (oka/merck) (VARIVAX) injection, one time, lot #X010535, expiration date: 11-APR-2025, administered for prophylaxis (strength, and route of administration were not provided) (Overdose). On that day, the patient should be vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) but measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) packaging was too similar (Product packaging confusion and Wrong product administered).
Patient reported nerve pain and tingling hours after the 2nd dose of Moderna. Patient reports the pain started to subside but sensitivity to textures remained.
rash (stomach and chest); redness injection site; pain injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash (stomach and chest)), VACCINATION SITE ERYTHEMA (redness injection site) and VACCINATION SITE PAIN (pain injection site) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042l20A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma and Hypertension. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), COLECALCIFEROL (VITAMIIN D PAIKESE) and AMLODIPINE for an unknown indication.    On 20-Jan-2021, the patient received eleventh dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced RASH (rash (stomach and chest)), VACCINATION SITE ERYTHEMA (redness injection site) and VACCINATION SITE PAIN (pain injection site). At the time of the report, RASH (rash (stomach and chest)), VACCINATION SITE ERYTHEMA (redness injection site) and VACCINATION SITE PAIN (pain injection site) had resolved. patient stated that he developed a rash all over his stomach and chest; zillion little dots. He stated some redness at first and some pain.      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.
pt recvd vax;05jul95 exp gen rash w/ five red, raised, liquid & pus filled tips;rash reported to be non specific dermatitis,pos follicular irritation; subsequently recovered;
My daughter fainted while doing her evening clean up chores at her coop. The next day 01/4, she when to be checked out at the health center. At that time she had her vitals checked no problems were noted except that she felt" unwell". She was told to return the next day if there was no improvement. The next day 01/5 she was still feeling unwell an (an "indescribable" fatigue, brain fog and headache). She is now unable to attend classes and is about to withdraw because she is so tired and fuzzy headed as well as now saying here eyes are having trouble focusing.
No additional AEs; temperature excursion; This spontaneous report was received from a registered nurse and refers to a 4-year-old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 06-DEC-2022, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) subcutaneous injection, lot #U039549, expiration date: 14-DEC-2023, administered subcutaneously for prophylaxis (dose and strength were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W018825, expiration date: 14-JUN-2024, administered subcutaneously for prophylaxis (dose and strength were not provided); diphtheria vaccine toxoid, pertussis vaccine acellular 1-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (DTaP-IPV), lot #G9N2M, expiration date: 14-APR-2024, administered intramuscularly (dose, strength, formulation, and indication were not provided) (product storage error).  On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. There was no adverse event reported.  The reporter considered temperature excursion to be not related to suspect vaccines.; Sender's Comments:  US-009507513-2212USA003061: US-009507513-2212USA007828: US-009507513-2212USA007829: US-009507513-2212USA007830: US-009507513-2212USA007831: US-009507513-2212USA007832: US-009507513-2212USA007833: US-009507513-2212USA007834: US-009507513-2212USA007835: US-009507513-2212USA007836: US-009507513-2212USA007838:
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The pharmacist reported that "sometime last week", approximately in September 2014, an unspecified number of patients received improperly stored ZOSTAVAX vial (dose, route and lot numbers not provided) due to the freezer experiencing defrost cycles. No adverse event symptoms reported. Additional information is not expected because there was no consent to follow up.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date in January 2018, the patient was vaccinated with expired dose of PROQUAD recombinant human albumin (rHA) 0.5 ml (lot # M032496, Expiry date : 02-JAN-2018) for prophylaxis (expired product administered). Concomitant therapies included sterile diluent(Manufacturer Unknown). The reporting nurse denied any adverse effects reported by patient.
Seen in our office on 10/9/07 for 4 year old WCU.  Rec'd DTAP, MMR, IPV, and Influenza.  Woke up on 10/11/07 with left arm slightly swollen, red,and warm to touch.  Progessivly got worse seen again in our office and diagnosed with post vaccine local reaction with cellulitis.  Treated with Keflex and Benadryl.
The vaccine was given at approximately 5:00pm without incident.  At 6:00am the next morning, the patient awakened with what she described as the worst stomach ache she'd ever had.  She quickly became cold, clammy, diaphoretic, light-headed, faint and began retching.  After about 15 minutes, this all passed and she felt OK.
Initial transient nausea.  In parking lot she had a headache and numbness in her ears.  No s/s of anaphylaxis or other more serious reaction.
Prolonged localized reaction. Some redness and soreness on upper arm, improved after first 3 days but still persists on day 10. Arm is still "sore" patient states. May 2018 episode of shingles was prolonged into late June, finally treated with VALTREX 1Gm TID for 7 days, then finally resolved.
Vaccine clinic was held at the center on 9/18/2021.  Pt received J&J vaccine at approximately 12:38 pm. Was instructed to sit at vaccination station for 15 minutes with staff after receiving vaccine. Pt stood up after receiving vaccination and began to talk with a person near chair where he was to sit. Pt girlfriend was present. Within one to two minutes of talking to person, pt fell to ground near recovery chairs/vaccine tent. EMS was close to clinic tent at time of event and one EMT witnessed fall. Writer and several EMTs responded to patient. Pt turned onto side. Eyelids were noted to be quivering for approximately 30 seconds.  One EMT reported she saw his eyes turn up into his sockets. Within approximately 1-2 minutes patient gained consciousness and began talking. EMT asked him name, dob, location which he was able to answer appropriately. EMT took BP, P, SpO2, and BG, and assessed patient. Pt given cool, damp cloth and began to talk more, then stated he was beginning to lose vision. He talked through this episode with staff present. Within approximately 30-60 seconds he began to regain vision.  Pt again able to state name, dob, and location appropriately. The ambulance then took this patient to Hospital for further evaluation. Writer unable to obtain any further detailed information about patient.
2 weeks after had flu like symptoms; Delayed reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (2 weeks after had flu like symptoms) and ADVERSE REACTION (Delayed reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (2 weeks after had flu like symptoms) and ADVERSE REACTION (Delayed reaction). At the time of the report, INFLUENZA LIKE ILLNESS (2 weeks after had flu like symptoms) and ADVERSE REACTION (Delayed reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was provided.  No lab data has been provided by the reporter.
Very bad numbness of the lower lip; A spontaneous report was received from a consumer, concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced very bad numbness of the lower lip (Hypoaesthesia oral). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 01-Mar-2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis. 27Feb2021 Patient visited physician and physician ruled out Bells Palsy. No treatment medication was reported. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event, very bad numbness of the lower lip (Hypoaesthesia oral) was considered to be not resolved at the time of this report.
MODERNA COVID-19 VACCINE EUA  cough, shortness of breath, wheezing, phlegm, 92% SpO2 blood oxygen  (asthma-like symptoms)
Vaccines administered at about 11AM.  Client left office about 15 min later with problems.  Mother called about 13:00 reporting hives on face/neck and facial swelling.  No other symptoms-breathing fine, no temperature.  Directed to ER.  Mother went immediately and child was given oral Benadryl and sent home with prescribed for Benadryl every 4-6 hours for 24 hours.
History of Present Illness: Patient is a 89 Y  female with a history of heart failure on Bumex(EF 2021 60-65%), hypothyroidism, hypertension, GERD, diabetes type 2 (not on any current antidiabetic medication), COPD(not on inhalers), pulmonary hypertension who presents to the emergency department after being found down in the garage by daughter.  History was provided by patient.  Patient states 1 week ago she attended a birthday-funeral event.  During this event patient interacted with approximately 17 other individuals, most of them who were young.  Subsequently, patient states she started to have episodes of cough with generalized weakness starting on Friday/Saturday.  At baseline patient ambulates with a walker.  Patient attempted to ambulate in the garage yesterday, however, was extremely weak and sat down on the garage floor.  Patient states she cannot get up and laid on the floor for approximately 16 hours.  Patient states daughter was attempted to call patient, however, patient was not reachable thus daughter came to patient's house.  Patient denies any loss of consciousness, denies hitting head.  Patient states she takes all of her medications as prescribed.
Per chart documentation child was vaccinated on 11/02/2021 and developed rash (pleomorphic, morbilliform) 2 days after MMR vaccine 11/04/2021 that resolved gradually per provider statement in chart. Per provider documentation, child was brought into clinic on 12/01/2021 due to complaints of rash, per documentation due to lack of insurance patient was taken to hospital, no treatment per said reaction to vaccine. Per provider documentation on 12/01/2021 skin appeared to have " faint traces of previous pleomorphic generalized maculopapular rash, provider provided reassurance to mom saying it was benign side effect of the measles components of the MMR.
This spontaneous case was reported by a  and describes the occurrence of ILLNESS (got sick), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (he did not feel good), NASOPHARYNGITIS (cold) and PAIN IN EXTREMITY (under arm was sore) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced ILLNESS (got sick), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (he did not feel good), NASOPHARYNGITIS (cold), PAIN IN EXTREMITY (under arm was sore) and MYALGIA (body hurt). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (ALKA SELTZER PLUS AND FLU) at an unspecified dose and frequency. At the time of the report, ILLNESS (got sick), INFLUENZA LIKE ILLNESS (flu like symptoms), FEELING ABNORMAL (he did not feel good), NASOPHARYNGITIS (cold), PAIN IN EXTREMITY (under arm was sore) and MYALGIA (body hurt) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided/unknown by the reporter.
This spontaneous report as received from a nurse refers to a patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX for prophylaxis reconstituted with properly stored sterile diluent. No adverse effects were reported. Data logger was involved. This is one of two reports received from the same reporter. Additional information is not expected. Sender's Comments: US-009507513-1708USA004467.
Child lost language, lost eye contact and stopped eating well.  Child stopped sleeping well.  Child developed behavorial issues/meltdowns (up to 50 meltdowns a day).  Child developed routines/rituals.  Child lined-up toys, spun-around in circles and stimms.    Child began early intervention at 2 years of age though Loudoun County.
incorrect diluent used for the shingrix vaccine. no adverse events or symptoms following the administration of this diluent with the shingrix
3/27: headache, fatigue 3/28: swollen lymph nodes, headache 3/29: itchy rash covering arms and legs with patchy areas on back and stomach; bottom lip swollen
Very suddenly, patient started producing large amounts of saliva, which he refuses to swallow, and at the same time, he began behaving as though he had a severe phobia of what he thinks are toxins, germs, and other "poisonous" or "dirty" (though invisible) substances. This was a severe and sudden onset, and the symptoms have not resolved at all. He's eating less and taking fewer fluids because he's afraid the food or beverage or the dish it touched, or even his own hands, are contaminated. Before his school closed again, he was unable to complete a whole day in kindergarten without significant anxiety, crying, trips to the school nurse (he used to love school, now he's afraid to go). It's affecting his ability to conduct a normal life. I am very concerned about his health. He's so afraid of food and drink that he's showing signs of dehydration such as constipation, chapped lips, and very dry skin. He's anxious all the time, and he has lost a lot of sleep. Often, these "OCD-like" symptoms are worst in the middle of the night. He wakes up and has hypersensitivity to tactile  sensations like he believes there's pee on his leg or  crumbs  p in his sheets. He gets very upset and about his hair touching him, it takes a long time to get back to sleep
covid vaccine breakthrough case  dose 1 1/6/21 Moderna 012L20A dose 2 2/3/21 Moderan 025J20A
About 23 hours after vaccination ... this was Moderna 2nd dose....began running fever of 101 degrees/alternating chills and hot flashes/serious stiffness in entire body/strong pain in lower back/lymph node left arm area (injection site) swollen/complete loss of appetite..   Severe symptoms lasted about 14 hours.  Lingering tiredness for three days following. I understand some symptoms are to be expected. I am an otherwise healthy, active male. The degree of this was a bit unexpected.
Information has been received from a licensed practical nurse concerning a patient (age and gender unknown) who on an unspecified date was vaccinated intramuscularly in the deltoid with a 0.5 mL dose of Pneumovax 23. Subsequently, on an unspecified date, the patient complained on injection site reactions. The patient sought unspecified medical attention. At the time of this report, the patient was recovering. No product quality complaint involved. Additional information has been requested.
Intense symptoms bad headache; Intense symptoms / Chills and shaking and couldn't hold a cup to drink; Intense symptoms / Muscles / ached and were painful; Intense symptoms / Joints ached and were painful; Intense symptoms / Bilateral lower back pain; Intense symptoms / Cough; couldn't hold a cup to drink; This case was reported by a nurse via other manufacturer and described the occurrence of headache in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced headache, chills, muscle pain, joint pain, low back pain, cough and movement disorder. On an unknown date, the outcome of the headache, chills, muscle pain, joint pain, low back pain, cough and movement disorder were unknown.   It was unknown if the reporter considered the headache, chills, muscle pain, joint pain, low back pain, cough and movement disorder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had intense symptoms bad headache, chills and shaking and could not hold a cup to drink, muscles and joints ached and were painful bilateral lower back pain and a cough. The events resolved but still had a dry cough and developed and odor, burning plastic and taste started to diminish.  Odor continued and no taste and pharyngitis.  No fever reported. For tolerances of 2nd dose, refer case US2021AMR028715, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR028715:Same reporter
pt recv vax 15JUL96 rash noted 21JUL & worsened over next 5 days;305m erythematous papules;pt fussiness;
Vomiting, dizziness. Gave water. Stable, released from vaccination site.
A spontaneous report was received from a consumer concerning a 57-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced intentional under dose.  The patient's medical history, as provided by the reporter, included cancer. Concomitant medications reported included acetylsalicylic acid and diabetic medication. The patient  is overweight but, doesn't know exact weight.  On 02 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011A21A) for prophylaxis of COVID-19 infection.   The patient had cancer in the past, and got 75% dosage. The reporter mentioned that the healthcare professional said it was the protocol to give 75% dosage to patient that previously had cancer.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event was considered as recovered on 02 Mar 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
PATIENT PRESENTED STATING SHE HAD HIGHER PAIN AFTER VACCINATION.  PAIN LEVEL HAD DECREASED AFTER A FEW DAYS.  ON 6 DAY PAIN LEVEL IS AT A CONSISTENT LEVEL OF PAIN.  PATIENT TAKES TYLENOL FOR PAIN RELIEF.
Information has been received from a 25 year old female registered nurse who in 1998 was vaccinated with MMR. The patient reported that her titer was negative. Unspecified medical attention was sought. The patient's outcome was unknown. No further information is available.
Information has been received from a health professional concerning an 11 yr old male who on 05Aug97 was vaccinated with a dose of varicella virus vaccine live. On 03Jun05 the pt experienced chickenpox lesions on his face and body and a red left eye. It was noted that the pt was generally healthy. Subsequently, the pt recovered. Unspecified medical attention was sought. No product quality complaint was involved. The pt's brothers experienced chickenpox following vaccination with varicella virus vaccine live (WAES0506USA03232 and 0506USA03233). Additional information has been requested.
No signs or symptoms reported.; A temperature excursion on VAQTA. Excursions occurred on 04/09/2021 and 04/23/2021. Company made aware of excursions on 05/12/2021. Doses were administered on 4/14/2021 and 05/07/2021.; Information has been received from an administrator, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On an unspecified date in 2021 (reported between 14-APR-2021 and 07-MAY-2021), the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated(VAQTA) lot # T017179, with expiration date on 26-OCT-2021 or lot # T014835, with expiration date on 17-JUL-2021 (dose, adminstration route and anatomical location were not reported) 1 "time dose" for prophylaxis. No signs or symptoms were reported, nor product quality complaints.  The vaccine had a temperature excursions of 49.0 Fahrenheit (F) and 48.7F on 09-APR-2021 and 23-APR-2021, respectively. The excursion last 1 hour and 15 minutes.It was confirmed that no previous temperature excursions occurred and no digital data logger was involved. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: v; expirationdate: 26-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability