chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient has complained of red welt just below injection site that is red and tender. Patient contacted pharmacy about this reaction 48 hours after the injection. Advised patient to apply some topical hydrocortisone 1 percent cream and monitor for signs and symptoms of infection including worsening of the area and streaking.
Arm still hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In SEP-2023, the patient received Shingles vaccine. In SEP-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm still hurt).The outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.   It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2023 This case was reported by a patient's husband via interactive digital media. The patient got shingles vaccine 3 days ago and arm still arm hurts. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR129925, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR129925:Same reporter
Herpes zoster reactivation shortly after administration of a mRNA vaccine; This is a literature report.  A 46 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing); "asthma" (unspecified if ongoing); "corneal abrasion" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: OPHTHALMIC HERPES ZOSTER (medically significant), outcome "recovering", described as "Herpes zoster reactivation shortly after administration of a mRNA vaccine". The event "herpes zoster reactivation shortly after administration of a mrna vaccine" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: investigation: discomfort, notes: the left eye 1 day after the Pfizer/BioNTech vaccine; vital dye staining cornea present: the corneal infiltrates, notes: were again seen. Therapeutic measures were taken as a result of ophthalmic herpes zoster.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on limited information in the case , a possible causal association between the reported  events Ophthalmic herpes zoster and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : PFIZER INC-202200174900 Same article/drug/event and different patient; PFIZER INC-202200206631 Same article/drug/event and different patient; PFIZER INC-202200206631 Same article/drug/event and different patient
It was reported by the PT that she was just exposed and had the 2 Imovax Rabies IM vaccinations administered Day 0 on 11/30/01 and again on Day 3 [12/03/01]. 5 days later [12/8/01] she developed hives on her face, then w/in 8 hrs all over her body. Physician treated her w/Zyrtec and Hydroxine. They are not working well.
On the 7th day after the vaccine shot my shoulder/arm where I got the shot got quite swollen. There was visible difference in the volume of my shoulder compared to the other one. The next day (8 days after the vaccine) there was a large (2-3 in wide and about 4 inches long) red spot over my arm that felt itchy, burning. The skin appeared to be dried out in that area and looked like a rash.
No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-MAR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T021826, expiration date: 25-JUN-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
booster; Patient had the Pfizer Booster dose and was taking air medication. Caller contacted before and waited for the confirmation for another booster dose of the patient.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Bnt162b2 (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; RESPIRATION ABNORMAL (non-serious), outcome "unknown", described as "Patient had the Pfizer Booster dose and was taking air medication. Caller contacted before and waited for the confirmation for another booster dose of the patient.". The lot number for bnt162b2 was not provided and will be requested during follow up.
Severe stomach cramps muscle pain and back pain. Extreme fatigue lasting more than 3 days.
This spontaneous report as received from a registered nurse refers to a 10 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 19-OCT-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M020102, expiry date: 08-MAR-2019 for prophylaxis. Concomitant medications were not reported. The patient was vaccinated at a private healthcare center and the vaccine was purchased with Private pay/ Insurance. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Patient came back on day after vaccination. She reported abnormal soreness & swelling. Upon exam her arm was red & warm to touch from inj site down to elbow. Arm also appeared slightly swollen. Patient advised to use diphenhydramine & follow if with MD if no resolution.
No additional AE's; a dose of PROQUAD was administered to a patient via the intramuscular route instead of the subcutaneous route; This spontaneous report has been received from a nurse regarding a patient of unknown age and gender. The pertinent medical history, concomitant medications and drug reactions/ allergies were not provided.   On 13-JUL-2022, the patient was vaccinated with measles (+) mumps (+) rubella (+) varicella (Oka/Merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) administered via intramuscular route instead of subcutaneous route (incorrect route of product administration) (strength, anatomical location, dose number and dose were not provided; lot #: W007746; expiration date: 04-SEP-2023) for prophylaxis (also reported as use as directed to prevent measles, mumps, rubella and varicella infection). No additional adverse events (AEs) and no product quality complaints (PQCs) were reported.
SORE ARM; This spontaneous report received from a patient via a company representative concerned a female 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, batch number: Unk) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced sore arm. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.
12 hours after the shot until 20 hours after the shot : fever up to 101.7; body aches; head ache; heart irregularities; fatigue. After the fever broke,  and after drinking "pedilyte" ( for potassium and elecrolytes to help with irregular heart beats) just fatigue. Not further affects as of now ( 71 hours after shot ).
9.2 x 4.8cm red lump 3cm indurated Lt arm warm to touch.
chills with goosebumps; extremely hot with chest; extremely hot with thigh; injection site was little tender; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills with goosebumps), CHEST PAIN (extremely hot with chest), FEELING HOT (extremely hot with thigh) and INJECTION SITE PAIN (injection site was little tender) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced CHEST PAIN (extremely hot with chest), FEELING HOT (extremely hot with thigh) and INJECTION SITE PAIN (injection site was little tender). On an unknown date, the patient experienced CHILLS (chills with goosebumps). At the time of the report, CHILLS (chills with goosebumps), CHEST PAIN (extremely hot with chest), FEELING HOT (extremely hot with thigh) and INJECTION SITE PAIN (injection site was little tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication include very low dose of cholesterol medication.   This case was linked to MOD-2021-060498 (Patient Link).
Missed second dose of Vivotif; Spontaneous report received on 23JAN2020.  A pharmacist reported that a consumer (unknown age and gender) who "missed second dose of Vivotif" (PT: Product dose omission), while being on Vivotif for immunization. The consumer missed the second dose of Vivotif, which was due on 22JAN2020. Action taken with Vivotif with respect to reported event was not applicable. At the time of report, the outcome of the reported event was unknown.  Company Comment: A consumer missed second dose of Vivotif. Considering the nature of the event, the causality of missed dose is assessed as not applicable with Vivotif.; Sender's Comments: A consumer missed second dose of Vivotif. Considering the nature of the event, the causality of missed dose is assessed as not applicable with Vivotif.
Pt failed to convert & was "not protected" p/series of 3 "Recombivax" vaxs, given 13OCT89, 13NOV89, & 13APR90; Pt completed a 2nd series of 3 vaxs (Engerix-B), given 7AUG90, 16OCT90, & APR91; Pt has not seroconverted;
his arm is much more sore than her arm; This is a spontaneous report from a contactable consumer (patient) via medical information team reported similar events for two patients. This report is for 2nd of 2 patient. This report is reported by consumer (wife) for a male patient (husband). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on 07Feb2021 as single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced sore arm. The reporter stated that she and her husband received their first dose of the Pfizer COVID-19 vaccine on Sunday, 07Feb2021, and his arm is much more sore than her arm. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Underaged patient received vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Underaged patient received vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Underaged patient received vaccine). On 15-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Underaged patient received vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drug was not reported. Treatment medication was not reported.
Full body rash; Hives; Itchy; swollen on chest, arms, hips, legs; swollen on chest, arms, hips, legs; swollen on chest, arms, hips, legs; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on 06May2021 at 15:30 (at the age of 23-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any allergies to food, medications, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06May2021, the patient experienced full body rash, looked like hives, itchy, swollen. On chest, arms, hips, legs. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events full body rash, looked like hives, itchy, swollen on chest, arms, hips, legs were recovered on an unknown date in May2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
lightheadedness, dizziness, nausea, vomiting. Lasted about 1 hour
Menstral cycle: heavier than normal and two weeks late. No possibility of pregnancy.  Dizziness, sore arm, slight nausea for two days after.
sick; High fever; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), PYREXIA (High fever) and VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 ILLNESS (sick), PYREXIA (High fever) and VOMITING (vomiting). At the time of the report, ILLNESS (sick), PYREXIA (High fever) and VOMITING (vomiting) outcome was unknown.
Patient develop severe cerebelitis with ataxia and dehydration requiring admnission in the Hospital for several days.
Base on data submitted in Immunization Registry and related registries . Patient received expired COVID -19 vaccine dose .
left shoulder to her lower arm is swollen; left breast is swollen.; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left shoulder to her lower arm is swollen) and BREAST SWELLING (left breast is swollen.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 immunisation.     No relevant medical history was provided.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (left shoulder to her lower arm is swollen) and BREAST SWELLING (left breast is swollen.). At the time of the report, PERIPHERAL SWELLING (left shoulder to her lower arm is swollen) and BREAST SWELLING (left breast is swollen.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No concomitant medications were provided by reporter.  No treatment medications were provided by reporter.
She drove it right into the bone and the patient went "ouch"; Intravenous in the arm; This is a spontaneous report received from contactable reporter (Consumer or other non HCP), Program ID. The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2), on 05Mar2020 as dose 2, single (Lot number: FJ8157) intravenous, in arm for COVID-19 immunisation. The patient's relevant medical history included: "Equilibrium issue" (ongoing); "High blood pressure" (ongoing); "Injury" (unspecified if ongoing). Concomitant medications included: AMLODIPINE oral taken for hypertension (ongoing); MECLIZINE [MECLOZINE] oral taken for balance disorder (ongoing). Vaccination history included: bnt162b2 (dose 1, single; lot number: EN6200; site: arm; time; AM), administration date: 12Feb2020, for COVID-19 immunization. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 05Mar2020, outcome "unknown", described as "Intravenous in the arm"; VACCINATION SITE PAIN (non-serious) with onset 05Mar2020, outcome "unknown", described as "She drove it right into the bone and the patient went "ouch"". Additional information: The patient had all 3 shots of Pfizer COVID-19 vaccine and booster and it worked. The first two doses were given at the patient's residence. Route was intravenous in the arm, injection in the arm. The time for administration of dose 2 of BNT162b2 was in the morning. The Pfizer vaccines that the patient received for COVID worked well. The only time he had a problem was when one of the people that administered it, she drove it right into the bone and the patient went "ouch, what are you doing". But other than that, the patient had no triggered effects. The patient got the booster when it was available for extra protection. The patient reported that the doses 1, 2 and 3 were wonderful. He would like to have some more this year.  Follow-up (14Aug2023): This is a spontaneous follow-up report received from a contactable consumer. Updated information included: Reporter information, patient detail (name and age group), medical history and concomitant drugs.  Follow-up attempts are completed. No further information is expected.  Follow-up (06Sep2023): This is a spontaneous follow-up report received from a contactable consumer (patient), Program ID. Updated information includes: event (added gender), medical history (added injury), event (added vaccination site pain), and additional information.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300263533 same patient and vaccine; different dose (4) and event; US-PFIZER INC-202300263551 same patient and vaccine; different dose (3) and event; US-PFIZER INC-202300263549 same patient and vaccine; different dose (1) and event;
Patient came to ED with shortness of breath.  Admitted to hospital with Covid pneumonia and hypoxia.  Treated with remdesivir.
pt recvd vax & appeared to be scratches going upward toward the shoulder; reporter states that pt was not scratched by inject needle; area felt warm to touch; pt was instructed to nofity reporter & MD of addtl or inc sx;
Patient informed me that they suffer from vasovagal syncope in the healthcare setting and "may" faint. The first vaccine was administered at 235 pm. The patient felt fine. The 2nd vaccine received by pt was Menveo. After administration of menveo pt informed pharmacist that they re light headed and may faint. Within 15 seconds pt lost consciousness for around 10 seconds. Pt was seated at the time of syncope. Pt's head was supported by pharmacist. Patient regained consciousness 10 seconds post syncope and requested water. a water bottle was given to pt. pt drank water and requested to lie down. Pt was laying in vaccination room for approximately 3 minutes before rising to chair. Pt was alert and able to confirm where they were and what happened. Pt refused for blood pressure to be taken and mention they were "ok" and that this happens with every vaccine. Around 5 minutes post syncope, pt stated they were good to leave and requested to go. I informed them I can take blood pressure and they can wait another 10-15 minutes. Pt refused and left. Pt was coherent and responsive upon leaving.
Started with chills at 8PM then quickly progressed to fever reaching 101.5 degrees. Fever remained from 11pm to 9am next morning. Other symptoms include extreme body aches (2 days), head ache (on and off for 2 Days), dizziness (second day), and possible vertigo (second day).  Pain at injection site for 2 days. Extreme fatigue for 36 hours.
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 33 years old male patient who received a dose of FLUZONE HIGH DOSE lot UJ024AC via intramuscular route in the right deltoid, by accident on 16-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose. It was not reported if any adverse event occurred or not. 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 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.
Swelling, soreness and redness at site of injection along pain with difficulty raising vaccinated arm (left deltoid).
epistaxis Narrative: States that ever since he received the 2nd dose of Moderna on 3/2/21, he's had some bloody noses and clots when he does sinus rinses. He reports these  have improved somewhat. He's been using saline solution. He feels hte ipratropium nasal spray makes this worse (thick mucous). He notably has a long history of sinus issues.
Hyperthyroidism. Irregular heart beat, trembling, fast pulse, joint pain,
pt recv inj 1115AM asleep following inj until 2PM;irritable & inconsolable, crying until early AM on 16MAY95; pt would not eat; vomited, refused feeding; diarrhea; fever, lump inj site, leg swollen, red, warm to touch
This 14 yr old came to clinic for well child visit. He was due for a varicella vaccine and was given ZOSTAVAX.