chrisvoncsefalvay/vaers-outcomes huggingface dataset:
came to the emergency room with altered mental status and unable to answer questions appropriately to the ER physician.  Since receiving IV fluids patient is now awake, alert and oriented x3.  He states he has not been feeling well for several weeks with decreased appetite, fatigue and loss of taste and smell.  He does not recall being confused but he does recall a "a family intervention. "  He denies fevers, cough or shortness of breath.  In the emergency room he was hypoxic with an O2 sat of 84% and found to have bilateral pneumonia and COVID positive.  7/24/2021 tested positive 7/28/2021: patient discharged. This is a pleasant 77-year-old male with a past medical history of diabetes who came to the emergency room with altered mental status and unable to answer questions appropriately to the ER physician.  Since receiving IV fluids patient is now awake, alert and oriented x3.  He states he has not been feeling well for several weeks with decreased appetite, fatigue and loss of taste and smell.  He does not recall being confused but he does recall a "a family intervention. "  He denies fevers, cough or shortness of breath.  In the emergency room he was hypoxic with an O2 sat of 84% and found to have bilateral pneumonia and COVID positive.  He also has acute renal insufficiency with mild elevation of AST.  His troponin is also 110.  According to EMS his O2 sat was 65% on room air.  Patient denies any chest pain.  He denies history of coronary artery disease.  He states he did get COVID vaccine with Moderna x2.  Patient appears to be going into SVT versus AFib with RVR.  Asymptomatic.     Patient denies any fever, cough, chills, rhinorrhea, sore throat, chest pain, shortness of breath, palpitations, orthopnea, paroxysmal nocturnal dyspnea, nausea, vomiting, diarrhea, constipation, hematuria, dysuria, frequency, melena, hematochezia or focal neurological complaints
Medical Assistant administered Pediarix, HIB, PCV 20 and Rota intended for another 6 month old patient.
Hiccups for 10 minutes,  indigestion, gas buildup , could not burp or expel gas, muscle pain around rib cage, back and chest,nausea, dizziness, fainting, vomiting,fell on floor and hit my nose which made it bleed. Did not stay unconscious for long, recovered quickly .had not pain afterwards took pepto bismal  for slight nausea then I felt all better. This all occurred between 9:30 pm to  12:30 am.
bells palsy; flu; Could not open or close his right eyelid; Hard time eating & drinking; Initial information received on 05-Feb-2021 regarding an unsolicited valid serious case received from a consumer (patient).  This case involved a patient of unknown age who experienced bells palsy (facial paralysis), flu (influenza), could not open or close his right eyelid (lagophthalmos) and hard time eating & drinking (dysphagia), while patient received vaccines INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, patient experienced bells palsy (facial paralysis), flu (influenza), could not open or close his right eyelid (lagophthalmos) and hard time eating & drinking (dysphagia), (latency: unknown) following the administration of suspect vaccine.  Seriousness criteria was assessed as medically significant as per important medical event (IME) list for the event facial paralysis.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the events were unknown.  There will be no information available regarding batch number in this case.; Sender's Comments: This case concerns a patient of unknown age who experienced facial paralysis, influenza, lagophthalmos and dysphagia after vaccination with suspect INFLUENZA VACCINE from unknown manufacturer. The time to onset is unknown. Moreover, medical condition at the time of vaccination and laboratory test ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
rashes on her entire body except face, arms,legs, neck,back,chest,belly; itching on both wrists; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on both wrists) and RASH (rashes on her entire body except face, arms,legs, neck,back,chest,belly) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS, VITAMIN E NOS and MAGNESIUM for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PRURITUS (itching on both wrists). On 13-Mar-2021, the patient experienced RASH (rashes on her entire body except face, arms,legs, neck,back,chest,belly). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Itchy skin, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itchy skin, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching on both wrists) and RASH (rashes on her entire body except face, arms,legs, neck,back,chest,belly) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On 08-NOV-2017, the patient was vaccinated with an expired dose of PROQUAD with lot number M021427 and expiration date on 29-OCT-2017, administered for prophylaxis (dose, dose number, route of administration and anatomical location were not provided). The reporter stated that the vaccine did not have any temperature excursions prior to administration. No adverse symptoms reported.
On 3/1/00, the child developed vomiting, diarrhea, and flu-like symptoms. He was seen by his pediatrician and a dx of dehydration and rotavirus was made. The pediatrician sent the child to an ER where he was given IV hydration for 5 hours.
received another 2nd dose by mistake the following day; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   In AUG-2023, the patient received the 3rd dose of Shingrix. In AUG-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received another 2nd dose by mistake the following day).The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 28-AUG-2023 The reporter called to ask about expected problems after receiving two 2nd doses of Shingrix, one day apart. He stated that his family member was in a nursing home and received her Shingrix first dose 2 months ago then received 2nd dose last week and she received another 2nd dose by mistake the following day, which led to extra dose administered. He refused to provide patient initials or exact age, stating that her age range is 75-80 years old. The reporter did not consent to follow-up.
This spontaneous report as received from a consumer via Clinic refers to a currently 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-SEP-2017, the patient was vaccinated with improperly stored dose of M-M-R II, recombinant human albumin (rHA) 1 dose unit (lot # M044350, Expiry date was not reported) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA000166:
Child was on Amoxil at the time for Otitis Media, took last dose of Amoxicillin, developed hives Sat AM, went to local ER, given Benadryl, hives continued 3-5-07 off and on, only other thing different was given hydrocortisone or to apply on dry patches, child was afebrile, not fussy.
Here is how the urgent care described my symptoms which lasted for about 2 weeks but occasionally have flared up to a lesser extent since: Left-sided chest pain, feels like his pectoral muscle has a weight on it.  This pain began almost immediately after he had received the Johnson & Johnson COVID 19 vaccinations 7 days ago.  It is a steady pressure in discomfort but it does not inhibit any type of physical activity or exercise.  No pleuritic component to this and no shortness of breath.   He is a nonsmoker and has had no known exposure to other people who been sick and there is no coughing or sputum production associated with this.  No loss of senses of taste or smell.  He still eating well and sleeping well but worried mainly that the this might represent some type of ?blood clot? since he just received vaccination just prior to onset of the symptoms. No history of underlying heart disease and no family history of early coronary disease.
Swelling in left side of face upon awakening next morning had subsided by 11 AM, no treatment.
headache; sore arm; This is a spontaneous report from a non-contactable consumer. A female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unknown date in 2021 the patient experienced headache and sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events headache and sore arm were recovered on an unknown date in 2021   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Information has been received on 14-NOV-2018 regarding a case in litigation from a lawyer concerning a patient of unknown age and gender. There was no information regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2010, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2015, the patient was treated by the patient's healthcare providers at a medical group for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Patient complained of dizziness. Assessment done, Vital signs taken. After 10 mins patient stated that she's feeling much better. patient sent home in stable condition. Patient educated.
it looked like pimples all over her back/they looked like blisters; painful and was like Shingles; pimple-like dot; itching on her back and shoulder; rash on the armpit inside the arm; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect. A contactable nurse (patient) reported that a female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on 06Feb2021 at single dose for COVID-19 immunization.  The medical history was not reported. The concomitant medications were unspecified pain medicines. The patient got the first Pfizer Covid-19 vaccine on Saturday morning on 06Feb2021. On Saturday night 06Feb2021 she noticed a pimple-like dot and it was itching on her back and shoulder and this was about 10-12 hours later after getting the vaccine. It spread very fast. Yesterday 07Feb2021 when she looked in the mirror, it looked like pimples all over her back. During the night, they looked like blisters and were down in the armpit area and painful. Were large blisters in the armpit and much bigger, but flat and is spread down inside of arms and were red and slightly raised and painful. Within 48 hours from time of injection, it is now flat, bigger, red, raised, and painful and it had gone down to her arm. They are tolerable and she doesn't have to take anything like pain medicines or anything. Thought it might be shingles on 07Feb2021 and she went online and they are not localized in one area of the back of shoulder. It happens to be on the same side she got the shot and spread down into the armpit and gone down the arm.  She also had a rash on the armpit inside the arm on 06Feb2021.  The rash was painful and was like Shingles and it happened instantly. Again mentions it all happened really fast within 48 hours. Wants to know if there are any reports of this or should she have gone to doctor or dermatologist to be looked at. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
rapid heart rate, chest tightness, butterflies in stomach. a week later pt broke out in hives and gland in left armpit gland was swollen
29AUG96 sl redness of peve noc; inc by morning;brought to clinic lt arm red, warm & swollen diameter 4 1/2";started 2 3/4" above elbow to above shoulder;no fever & did  not c/o pain on movement;16SEP96 mom states local redness disappe
After 25 minutes started coughing, shortness of breath, wheezing, vitals taken,albuterol inhaler administered, wheezing and shortness of breath improved
Narrative: 62 yo male with past medical history including EtOH/HCV hepatitis with liver transplant in Dec 2020, HTN, GERD reported to the Emergency Department for COVID symptoms on 9/7/2021. Reported chills, fatigue, nasal congestion, sore throat, cough, body aches, diarrhea for 10 days. For hepatitis C, he completed Mavyret therapy in April and is currently taking Tacrolimus 3mg AM and 2mg PM as well as mycophenolate 500mg BID. He states compliance to both meds, has not missed any doses. -Date of positive COVID-19 test: 9/7/21, despite being fully vaccinated with Pfizer's COVID vaccine on 1/29/2021 and 2/22/2021 -Date of symptom onset (estimated based on chart review): approx 8/29-8/30 -High risk factors identified: immunosuppressant therapy, BMI >/= 25 - Recommendation: Patient is considered at high risk for progression to severe disease and/or hospitalization based on risk factor(s) identified above. He was offered MAB infusion by ED provider and accepted. The agent and dose are documented elsewhere in this report. 5 days later he reported to the Emergency Department again, stating that he felt worse with increased weakness and dyspnea with significantly decreased oral intake. Overall, he did not have difficulty breathing. In the ED, he was afebrile, HR 60s, BP elevated to 176/112, and satting >98% on RA. Labs revealed WBC 5.3, Hg 13.3, Plts 102, K 3.6, Mg 1.6, Cr 1.32, trops and BNP neg, AST 39, ALT 11, Alk Phos 131. CXR showed patchy bilateral airspace opacities more notable in the lower lobes. He was admitted to treat empirically for community acquired pneumonia given that he's immunocompromised, and monitor on continuous pulse ox for consideration of remdesivir/dexamethasone. Patient did not require oxygen during his brief stay and did not require remdesivir or dexamethsone. He was discharged in stable condition on 9/14/2021.
Patient reports blisters on the back of her tongue. She doesn't know when they appeared. They are not painful.
Fever of 102 with onset at midnight after vaccination,a long with  chills, muscle aches, some nausea,--subsided after a few hours.    headache  and tiredness the morning after
Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from an-other health professional. This case is linked to cases 2018SA274341 and 2018SA274344 (same reporter). This case involves an 8 years old patient (gender not reported), who was vaccinated with a dose of DAPTACEL (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date (second patient). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration because children's of greater than 6 years old are vaccinated. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
pt recv vax 12FEB99 & 30min post vax pt exp diff swallowing & a swollen tongue;these adverse exp were considered to be other medical events;pt went to ER & given epi;the reporter felt that diff swallowing & swollen tongue were r/t to vax;
I have developed a skin irritation on my face and neck that I have never had before. It appears to be symptoms similar to eczema. There has been no change in diet or skin care in the past year.
tired; Pain was just for 10 min; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (tired) and VACCINATION SITE PAIN (Pain was just for 10 min) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired) and VACCINATION SITE PAIN (Pain was just for 10 min). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and WATER at an unspecified dose and frequency. At the time of the report, FATIGUE (tired) outcome was unknown and VACCINATION SITE PAIN (Pain was just for 10 min) had resolved.            Patient was not on any concomitant medications. The patient had received all the previous doses of the Moderna COVID-19 vaccines and reported nothing big in terms of side effects, just being tired. The patient reported she had not been sick with COVID, even though she was around people with COVID. The treatment medication included: Gatorade
Pt reported redness from top of arm to elbow and had a golf ball size swelling around injection site. did apply ice while helped with swelling and did take 2 doses of benadryl which helped with redness. as of now 1/20 just slightly sore all redness has subsided. pt did follow up with doctor he said very common reaction/side effect associated with pneumovax 23.
The patient was being seen for a well visit.  The Medical Assistant placed an order in his EMR for Bexsero instead of Menveo.  The doctor who reviewed the patient's order did not catch the error and signed the order. Bexsero was administered instead of Menveo (the required vaccine). The parent was notified and the patient was scheduled to return to the clinic for the correct vaccine.
Pt returned to pharmacy approx. 25 minutes after receiving vaccination saying that her "tongue felt full," difficulty swallowing, and she "felt warm/flushed." Epipen 0.3 mg administered at 7:01 om on 7/21/14. 911 called and EMS arrived within 5 minutes. EMS transported to local hospital.
p/recv vax pt exp irritability & difficulty nursing; cried for several hours; glassy eyes; mom states was miserable 4-5 days;
LOWER BACK PAIN; UPPER LEG PAIN; INNER KNEE PAIN; BRIEF SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight was 130 pounds, and height was 160.02 centimeters. The patient's concurrent conditions included asthma, allergic to reglan, non smoker, and non alcohol user, and other pre-existing medical conditions included no drug abuse or illicit drug usage.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and batch number: 207A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for pain in extremity. On 10-APR-2021, the subject experienced brief shortness of breath. On an unspecified date, the subject experienced lower back pain, upper leg pain, and inner knee pain. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) No clots were found. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from brief shortness of breath, and had not recovered from upper leg pain, lower back pain, and inner knee pain. This report was non-serious.
Patient  was administered vaccine after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient  was administered vaccine after the manufacture date of expiration) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient  was administered vaccine after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient  was administered vaccine after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that vials had not undergone any temperature excursion.  Date the vial was initially stored in the refrigerator was unknown.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non significant information.