chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PNES (psychogenic nonepileptic spells); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PSYCHOGENIC SEIZURE (PNES (psychogenic nonepileptic spells)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PSYCHOGENIC SEIZURE (PNES (psychogenic nonepileptic spells)). The patient was treated with LORAZEPAM (ATIVAN) on 03-Feb-2021 for Convulsions, at a dose of 1 dosage form and EPINEPHRINE on 03-Feb-2021 for Convulsions, at a dose of 1 dosage form. At the time of the report, PSYCHOGENIC SEIZURE (PNES (psychogenic nonepileptic spells)) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2021, Electroencephalogram: pnes (abnormal) PNES (psychogenic nonepileptic spells).         Patient began having major convulsions within 10 minutes of receiving second dose, and was transported to the emergency room (ER). On 03-MAR-2021, patient's neurologist diagnosed with PNES (psychogenic non epileptic spells) requiring CBT (Cognitive behavioral therapy).   This case was linked to MOD-2021-046737 (Patient Link).
28hr p/vax pt had fever of 105-106;also had vomiting & diarrhea;dx w/OM
I have always gotten the seasonal flu shot/vaccine. Both ears began to pulsate when I went to bed (incline position), sounds like my heartbeat is in my ears. By Saturday, I had facial twitching and right arm weakness. By Sunday, I had right arm weakness. By Monday, my left elbow hurt with any movement.
Patient was here to receive 2nd dose of pfizer to complete primary series.  Patient received the bivalent pfizer dose instead.  Patient is not experiencing any adverse effects and was told to contact us if that changed.
Intense itchiness from thighs to neck leaving behind swollen red lines when scratched. Dermatographia? Applied aloe vera and took Benadryl, which seemed to help Itchiness first started about 4 - 5 hours after shot, and has thus far continued ~28 hours later
Info has been received from an RN concerning a 4 year old white male no allergies or medical history who on 8/15/02 was vaccinated with a dose of varicella virus vaccine live at a shot clinic. Concomitant medication given on the same day at the shot clinic included: a dose of hepatitis B virus vaccine rHBsAg (yeast), a dose of MMRII and a dose of poliovirus vaccine inactivated. No illness was known at the time of vaccination. On 8/20/05, the pt was seen in the office with a mild case of chickenpox characterized by a generalized skin rash of less than 100 lesions noted trunkcally with mild upper respiratory symptoms (cough). No fever or other symptoms were noted. No diagnostic or lab tests were performed. It was noted that the symptoms started on the morning of 8/19/05. The pt was treated with Tylenol and Benadryl as needed. At the time of the report, the adverse event had not improved. A product quality complaint was not involved. Additional info has been requested.
First symptoms was not able to walk. had only treatment at hospital IV-IG. Went back to rehab until 1-4-14. Came home and have continuous pain in hands, legs and feet.
Headache, Rash, arm pain and swelling; rash; headache Narrative:
This spontaneous report as received from a nursing assistant referring to an unspecified number of patients of unknown age and gender. On an unknown date, years ago, the patients were vaccinated with an unspecified flu vaccine (manufacturer, route, lot # and expiration date were not provided) and after PNEUMOVAX 23 (route, lot # and expiration date were not provided). On an unknown date, years ago, couple of times, the patients developed red and swollen arms. It was unknown if the patient's sought medical attention. At the time of the report, the patients status was unknown. Additional information has been requested.
diarrhea (golden color) that occur 2-3x a week; Shoulder ache; A spontaneous report was received from a consumer concerning a 89-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Shoulder ache and diarrhea (golden color) that occur 2-3x a week . The patient's medical history was not provided by the reporter. Concomitant medications include Metformin ,digoxin, Hydrochlorothiazide ,Levothyroxine ,propranolol, losartan and acyclovir. She had taken Bismuth Subsalicylate to treat  Stomach relief . On 24 Jan 2021  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) via intra muscular  in unknown anatomical location for prophylaxis of COVID-19 infection.  After receiving the first dose ,the patient experienced shoulder ache pain for couple of hours . On 26 Jan 2021 patient experienced diarrhea (golden color) that occur 2-3x a week. Diarrhea is still evident.  Action taken with mRNA-1273 in response to the events was not unknown. The events of outcome  shoulder ache was Recovered /Resolved and the outcome of diarrhea was unknown.
1st dose administered to 14 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 14 year old) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 14 year old). On 01-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 14 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.   No treatment medications were provided.  Pharmacy accidentally administered a 1st Moderna dose to a 14 year old
pt describe rt deltoid as feeling achy, crampy in upper part of arm from elbow to shoulder;red x 1 days +- 2" in diameter, some itchiness;rt arm cont to be achy, crampy but is resolving (11 days);pt taking advil as needed;
Tenderness and soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Additional details reported were as follows: The case was self reported by the patient. The patient received Shingrix in September of last year. The patient had tenderness and soreness at the injection site that resolved 2 days later. The representative spoke from content and package insert. The reporter consented to follow up. Consent obtained to contact health care professional and consumer for follow-up. For tolerance of 2nd dose, refer case US2022AMR045382.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR045382:Same Reporter
Information has been received from a 74 year old male patient reporting on himself. The patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On an unspecified date in March 2017 (reported as a week and half ago), the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) (dose, frequency, anatomical location, lot# and expiration date were not provided), intramuscularly, for prevention of shingles. On an unspecified date in March 2017 (reported as approximately a week after the administration of the ZOSTAVAX, the patient experienced sinus infection and canker sores. The patient went to see his physician and was prescribed an unspecified medication. The patient's outcome was reported as not recovered. The causality assessment between ZOSTAVAX and the adverse events was not provided. Additional information has been requested.
PATIENT WOKE UP THE NEXT MORNING FOLLOWING THE SHOT AND FELT DISORIENTED . SHE STATED SHE WAS ATTEMPTING TO DRESS HERSELF WHEN SUDDENLY SHE PASSED OUT. ACCORDING TO HER HUSBAND (WITNESS), HER EYES JUST WENT BACK INTO HER HEAD AND THEN SHE WENT DOWN. SHORTLY LATER SHE CAME TO, DECIDED TO GO BACK TO BED. LATER THAT DAY SHE WOKE UP FEELING NORMAL.  SHE HAD NOT STARTED ANY NEW MEDICATIONS AND THIS IS NOT SOMETHING COMMON THAT HAPPENS TO HER.
69y.o. year old male who presented to ER at request of his PCP Dr. due to diagnosis of Covid. He was tested because a number of his work contacts tested positive.  He is very anxious and is sorry he came to hospital because he wants to go home. He suffers from anxiety. This is a 69y.o. male Admitted by my associate his PCP from the emergency room the recurrence of some concerns regarding Covid-like symptoms with having a cough rhinorrhea sore throat muscle aches and loose stools and shortness of breath initially was Covid negative as test elsewhere was Covid positive and he was sent to the emergency room he is having a hard time catching his breath and having shortness of breath no chest pain or pressure no nausea vomiting he states he had fevers and chills when I saw him this morning he was feeling slightly better he is Covid vaccinated with Pfizer.  He is currently on oxyg
Pt called on 5/7/2021 to report that she developed gout symptoms in her toe 'a few days' after both doses of her Covid vaccine. Last dose was 3 weeks ago. Describes redness, swelling, and pain in right great toe. States her last flare was 'several years ago.' She does not normally treat flares and did not do so after symptoms developed following her first Covid vaccine dose. Symptoms resolved between first and second dose. States the pain has been more severe in recent days. Wanted to notify vaccinator for reporting purposes. Scheduled to see her PCP next week; however, also requested to be seen at our clinic if we were able to see her earlier (no appts available, but a provider did speak w/ her by phone as part of this report). After review of symptoms and medical history by phone and without more recent lab results and treatment plans available in our records, advised pt of limited treatment options. She declined steroid dose pack due to diabetes and plans to manage at home until able to see her provider.
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Alcohol use stopped in 29-DEc-2020). Family history included Prostate cancer (Paternal grandfather), Gestational diabetes (Mother) and Diabetes (Father and grandfather). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 29-Dec-2020 and the estimated date of delivery was 04-Oct-2021. On 03-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Ultrasound scan: normal (normal) Ultrasound scan normal. On 15-Mar-2021, Ultrasound scan: normal (normal) Ultrasound scan normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient takes Green Tea for sleep.  No treatment information was provided.
On the Monday and Tuesday (March 22 and 24) after I got the second vaccine, I had some minor wheezing. On Wednesday I got a very bad sore throat on the right side. I had intense headaches. The pain moved unilaterally to the right side of my head, ear, and neck. It was very painful. I went to see medical center on Thursday. I tested negative for Covid 19 and Strep. This pain persisted until today, March 28 (4 days)
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Medium
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 40 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816022, expiry: 29-SEP-2021) dose was not reported, administered on 04-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-OCT-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
A GlaxoSmithKline sales rep reported that she received info. from "some" physicians who reported that "some" of their subjects experienced burning at the inject site after receiving Hep B vaccine recombinant (Engerix-B). The subjects' medical histories, concurrent medical conditions, and concurrent medications were not specified. On unspecified dates, "some" subjects received Hep B vaccine recombinant in unspecified sites and dosages. At some point after receiving the vaccine, the subjects complained of burning at the inject site. The outcome of these events was not specified. Comments: The physicians indicated that "some" subjects experienced burning at the inject site; however,, the subjects are not presently identifiable. Additional reports will be generated when identifiers are provided.
Itchy spot 4 inches diameter on injection site.  Intensified for 3 days to a slight bump 1 inch wide day 5 has gotten better.  Day 6 even better.
Pt recvd DTP/OPV/MMR 27AUG91 & devel fever & swelling which lasted 1.5 days; Late evening on 31AUG91, pt father noted tiny pustules on inject site which popped open that resulted into open abscess; Given ATB;
Patient received initial dose of 0.25 ml dose of Moderna Bivalent vaccine instead of Monovalent vaccine; 5 year old received initial dose of 0.25 ml dose of Moderna Bivalent vaccine; Redness to injection site; This spontaneous case was reported by a medical assistant and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness to injection site), WRONG PRODUCT ADMINISTERED (Patient received initial dose of 0.25 ml dose of Moderna Bivalent vaccine instead of Monovalent vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 year old received initial dose of 0.25 ml dose of Moderna Bivalent vaccine) in a 5-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. In 2022, the patient experienced VACCINATION SITE ERYTHEMA (Redness to injection site). On 04-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received initial dose of 0.25 ml dose of Moderna Bivalent vaccine instead of Monovalent vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 year old received initial dose of 0.25 ml dose of Moderna Bivalent vaccine). At the time of the report, VACCINATION SITE ERYTHEMA (Redness to injection site), WRONG PRODUCT ADMINISTERED (Patient received initial dose of 0.25 ml dose of Moderna Bivalent vaccine instead of Monovalent vaccine) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 year old received initial dose of 0.25 ml dose of Moderna Bivalent vaccine) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.    No treatment information was reported.
administered Moderna vaccine booster doses after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna vaccine booster doses after the published expiration date) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna vaccine booster doses after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna vaccine booster doses after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug information was provided.   No treatment drug information was provided.
Information has been received from a licensed practical nurse referring to multiple patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (lot # L050910, expiration date 14-JUN-2017, therapy type: rHA; lot # M004894, expiration date 26-JUL-2017, therapy type: rHA, dose and route not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt received first dose of COVID-19 vaccine on 2/12/2021.  Pt presented to ED 2/18/2021 with shortness of breath and confusion.  He reported having an exposure to someone positive for COVID-19 prior to date of vaccination but was unaware of exposure until after.  Pt had findings indicating pneumonia on chest X-ray and required supplemental O2 with admission to hospital (2/18/2021). Pt was discharged the evening of 2/21/2021.
I got a red, blotchy, itchy, rash all over my arms and legs. I went to urgent care and they said to take Benadryl but it did not help. I then got a prescription for prednisone (20 mg per tablet, two times per day). This helped but I had to continue taking the pills for five days. if I tried to stop, then the rash and itchiness would come back. I also had minor fever even a week after vaccine.
This spontaneous report has been received from a nurse practitioner via a company representative concerning a male patient of unknown age. The patient's concurrent conditions and pertinent medical history were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (Lot #, exp. date, strength, route of administration and dose were not provided). There was no concomitant medication reported. On an unknown date, the patient experienced dizziness and almost fainting after receiving GARDASIL 9. The patient sought medical attention in the office only and received an ice pack and water to recover at the office before leaving. However, the outcome of dizziness and almost fainting was not reported. The causal assessment of dizziness and almost fainting to GARDASIL 9 was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Swelling and tenderness in right armpit/lymph nodes first observed on Jan 15, 2022. Swelling and tenderness have slowly been subsiding but are still present on Jan 19, 2022.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Pt fainted a minute after recieving his vaccine. Was unresponsive for a few seconds and got up after. Bite his tongue from the fall head first. Paramedics were called and he was quickly evaluated with no vitals out of range. He went home and napped and after follow up call, feels better now 7 hours later. He confirmed had light headache,was tired so napped and also had tingling in his arm and also confirmed he did not drink water or eat anything before his visit. Now he feels fine.
Patient stated she had pain in left arm since Monday night, continuing through Thursday when she cam into pharmacy. She stated she had swelling and redness. She had a red band around the arm, below the injection site but above the elbow. She stated she didn't use any treatment (no ice, no ibuprofen, etc).
2ml of normal saline was used to reconstitute the vaccine instead of the directed 1.8ml. No adverse effects reported.
Inadvertently took a 3rd shot the 2nd one 4 years ago; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date) and Shingles vaccine (2nd dose received 4 years ago).   On 22nd June 2022, the patient received the 3rd dose of Shingles vaccine. On 22nd June 2022, unknown after receiving Shingles vaccine, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 22-JUN-2022 Reporter's Comments: This case reported by consumer via interactive digital media. The patient self-reported this case. The patient inadvertently took a third shingles shot 15 minutes before reporting.  The patient forgot that he or she had taken the second one 4 years ago and asked that what he or she should do. Follow-up would not be possible as no contact details available. Additional supportive information: The patient received 3rd dose of Shingles vaccine which led to extra dose administered.