chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling arm; Diffuse redness surrounding the injection site; This non-serious case was reported by a other health professional and described the occurrence of injection site erythema in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 95252, expiry date 18-JUN-2024) for prophylaxis.   On 11-JUL-2023, the patient received Shingrix (intramuscular). On 12-JUL-2023, 1 days after receiving Shingrix, the patient experienced swelling arm (Verbatim: Swelling arm). In JUL-2023, the patient experienced injection site erythema (Verbatim: Diffuse redness surrounding the injection site). The patient was treated with paracetamol (Apap) and benadryl (nos) (Benadryl). The outcome of the injection site erythema was not reported and the outcome of the swelling arm was not resolved.   It was unknown if the reporter considered the injection site erythema and swelling arm to be related to Shingrix.     It was unknown if the company considered the injection site erythema and swelling arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-JUL-2023 Patient was treated with APAP and Benadryl for swelling arm. On 13th July 2023, the outcome of event swelling arm was not reported. The reporter consented to follow up.
influenza-like viral infection mid-Oct-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INFLUENZA LIKE ILLNESS (influenza-like viral infection mid-Oct-2022) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Primary series given as per Label) in January 2021 and PFIZER BIONTECH COVID-19 VACCINE (Primary series given as per Label) in February 2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2022, the patient experienced INFLUENZA LIKE ILLNESS (influenza-like viral infection mid-Oct-2022). At the time of the report, INFLUENZA LIKE ILLNESS (influenza-like viral infection mid-Oct-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Home COVID test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No known history of Covid-19 Infection.  Patient had received booster dose.                           No treatment information was provided.   This case was linked to MOD-2022-675627 (Patient Link).
Patient Reported: "Received some two series Shingle shot.  On weds got the shot by evening wasn't feeling real well, but for reason's of going in for check up figured continuing of same issue.  Next morning Thursday I was deathly sick. Even stated I was going down.  Made it through Thursday, sick all day, dizzy/disoriented/wasn't hungry.  Friday read my paper work from my visit too doctors and what to expect via the shingles shot.  My summation it was a bad affect from the Shot.  At the time didn't even associate it too the shot, I did have a shot in 2011 but guess this is suppose to be improved." On 11/4: "Current status is good,  but last  11/29  I was deathly ill.  as stated was disoriented / Dizzy / very unstable  But 11/30 was feeling 100% improved. I was down a day"
she can't see she can't get in the highway to drive; she can't get in the highway to drive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISUAL IMPAIRMENT (medically significant), outcome "unknown", described as "she can't see she can't get in the highway to drive"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "she can't get in the highway to drive". Clinical course: Patient was a nurse and worked in operating room and had to go to the hospital she could not see she could not get in the highway to drive, and this was a side effect of the vaccine.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On 1/28 i received my first dose of Moderna Vaccine.  After the 1st day, Friday, the next morning i was feeling bad.  a bad headache, stuffy sinuses, a little dizzy. By later that afternoon, i was feeling better.  Saturday morning i am still not feeling myself but still improving.  Sunday i go to work, someone i work with comes in contact with someone else who just testes positive for Covid, and tells us. At this time my crew and i are told to quarantine for 4 days. Now on Feb.4th, i just tested positive for Covid-19, but symptom free.
arm is all red; swollen from elbow; Arm is all swollen; This is a spontaneous report from a contactable consumer (reported for her brother). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 23Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced arm is all red, swollen from elbow, arm is all swollen. Reporter stated, her brother had a shot yesterday (Further confirmed as 23Mar2021) afternoon and his arm is all swollen and it is all red. she wanted to know Is that a normal side effect or should we be concerned. The outcome of event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
No additional AE reported; Improperly stored product administered; This spontaneous report was received from a physician  and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 17-NOV-2020,  the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) Lot # T025506, expiration date 23-JAN-2022, 0.5 milliliter for prophylaxis (route of administration not reported).     The improperly stored dose of the suspect vaccine experienced a temperature excursion of 22.8 degree fahrenheit (°F) for 13 hours and 25 minutes with a previous temperature excursion of 17.4 °F for 31 minutes and 30 seconds. The call was made due to a digital data logger. No adverse symptoms were reported.
Information has been received from a physician concerning a 13 month old patient who in approximately 1999 (reported as five years ago), was vaccinated with varicella virus vaccine live. The physician reported the patient developed cellulitis at the injection site a few days after the injection. The patient was seen in the emergency room and subsequently admitted to the hospital The patient's symptoms were redness, pain, and swelling of the leg. After a stay in the hospital (unknown duration) and unknown treatment, the patient's symptoms resolved and the patient recovered from cellulitis. The cellulitis symptoms, redness, pain and swelling of the leg were considered a significant disability/incapacity. Additional information has been requested.
Information has been received from a physician concerning a 16 year old white female who on 15-NOV-2007 was vaccinated in the right deltoid with her first dose of GARDASIL (lot# 655154/1210U). There was no concomitant medication. On 16-NOV-2007 the patient suffered a severe headache and fever greater than 100F. Subsequently, the patient recovered from the severe headache and fever. Additional information has been requested.
Patient reported getting cellulitis and having a migraine since receiving both vaccines.  Patient has reported that she went to both urgent care and the hospital, but dates of visits are currently unknown.
Bruise; Car sickness; Migraine; Itchy rash; Red rash; Painful rash; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruise), MOTION SICKNESS (Car sickness), MIGRAINE (Migraine), RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CONTUSION (Bruise), MOTION SICKNESS (Car sickness), MIGRAINE (Migraine), RASH PRURITIC (Itchy rash), RASH ERYTHEMATOUS (Red rash), RASH (Painful rash) and NAUSEA (Nausea). At the time of the report, CONTUSION (Bruise), MOTION SICKNESS (Car sickness), MIGRAINE (Migraine), RASH PRURITIC (Itchy rash), RASH ERYTHEMATOUS (Red rash), RASH (Painful rash) and NAUSEA (Nausea) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  No treatment medications provided by the reporter.
11/12-spoke with Inf. control nurse, stated patient being correct up for lymphoma cadevice.
This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient is immunocompromised and only received two primary care series doses of the Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concurrent medical conditions included Leukemia and Immunocompromised. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient is immunocompromised and only received two primary care series doses of the Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient is immunocompromised and only received two primary care series doses of the Moderna Covid-19 vaccine.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: Leukemia with low counts of white blood cells. No concomitant drug information was provided. The patient was immunocompromised and only received two doses of primary series of the Moderna vaccine. The patient had leukemia with low counts of white blood cells. The patient never received a third primary series dose. No treatment drug information was provided.
Directly after shot mild: swelling at the injection site and pain  Starting 1 Week after vaccine date: Full body aches and pains, eventually turned to severe aches, pains, confusion, 104F fever, and elevated inflammation levels requiring hospitalization on 7/29/22  and was held in hospital until 8/2/22
Patient states she experience severe soreness ( swollen and tingling ) in arm, which caused generalized malaise and ER visit
20 min after receiving vaccines pt with red rash along (L) leg spreading up and 1 small area on (R) ankle. No wheezing, SOB, swelling. No rash noted elsewhere. No s/s RXN at site of inj. Started on PEDIAPRED and BENADRYL, GM to monitor for s/sx worsening
Patient first reported today at presentation for second dose that his Right arm  became sore soon after Moderna Administration of first dose.   The soreness improved substantially but  is still sore in a certain area when patient  lifts his arm so high.   Movement around the joint is not restricted or limited.  Dr was notified of the event today.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (strength, dose, frequency and route of administration were not provided) lot # N026073, expiration date 20-SEP-2019 for prophylaxis. Concomitant therapies included sterile diluent (MRK). The doses of VARIVAX were exposed to a temperature excursion of 6°Fahrenheit (°F) to 14°F (8.8°F) during a time frame of 1 hour and 18 minutes, which was detected by the data logger. There was no previous temperature excursion. No adverse effects were reported. Sender's Comments: US-009507513-1804USA003063: US-009507513-1804USA003064: US-009507513-1804USA003065: US-009507513-1804USA003066: US-009507513-1804USA003067: US-009507513-1804USA002453: US-009507513-1804USA003069: US-009507513-1804USA003070: US-009507513-1804USA003071: US-009507513-1804USA003072: US-009507513-1804USA003073: US-009507513-1804USA003074: US-009507513-1804USA003075: US-009507513-1804USA003062.
SWEATING; CHILLS; HEADACHE; FEVER; CHEST PAIN; LITTLE DIZZY, BUT NOTHING TOO CRAZY; BODY ACHES; This spontaneous report received from a patient concerned a 50 year old male. The patient's weight was 188 pounds, and height was 68 inches. The patient's concurrent conditions included: disabled veteran (multiple chronic conditions), penicillin allergy, sulfa allergy, bee sting allergy, non smoker, and non alcoholic, and other pre-existing medical conditions included: Patient had no drug abuse and illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2022) dose was not reported, administered on 26-OCT-2021 14:30 for prophylactic vaccination. No concomitant medications were reported.  On 26-OCT-2021, the patient experienced chest pain. On 26-OCT-2021, the patient experienced little dizzy, but nothing too crazy. On 26-OCT-2021, the patient experienced body aches. On 26-OCT-2021, the patient experienced chills. On 26-OCT-2021, the patient experienced headache. On 26-OCT-2021, the patient experienced fever. On 27-OCT-2021, the patient experienced sweating. Laboratory data included: Body temperature (NR: not provided) 105 F, 103 F, 102 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, and little dizzy, but nothing too crazy on 26-OCT-2021, had not recovered from body aches, headache, and fever, and the outcome of chills and sweating was not reported. This report was non-serious.
COVID-19/SARS-CoV-2 test positive; COVID-19/SARS-CoV-2 test positive; Vaccine breakthrough infection; COVID-19 Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. Other Case identifier(s): 2022NVX-US-000004137.  A 91-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EM9810), on 04Mar2021 as dose 2, single (Lot number: En6201) and on 02Nov2021 as dose 4 (booster), single (Lot number: 30155BA) for covid-19 immunisation; coviD-19 vaccine prot. subunit (nvx cov 2373)  COVID-19 VACCINE), on 30Mar2021 as dose 3 (booster), single (Lot number: 30155BA) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant) with onset 30Mar2021, outcome "not recovered", described as  COVID-19 Vaccine"; VACCINATION FAILURE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 19Oct2022, outcome "not recovered" and all described as "COVID-19/SARS-CoV-2 test positive"; VACCINE BREAKTHROUGH INFECTION (hospitalization) with onset 19Oct2022, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Oct2022) Positive, notes: 19Oct2022 SARS-CoV-2 test, Positive. Case Description: On 24Oct2022, this serious, initial Regulatory Authority Safety Report was received via (Institution name withheld) via Vaccine Adverse Event Reporting System and was received on 07Nov2022. Original reporter type is unknown.
104 temp/chills, worst headache I've ever had (and I have migraines), vomiting, skin felt like it was on fire, aches, sinus, sore throat. (My husband age 59 reacted as well with fever of 102, aches, sinus).
This spontaneous case was initially received on 05-Nov-2015. The case report was received from a Non Health Professional and concerns a male patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA on 08-Oct-2015, Batch no: 12149211A, Route of administration: Intramuscular, Dose: 0.5 ml. No additional drugs suspected. On an unknown date, 1 week 0 days after starting treatment with AFLURIA the patient experienced anxiety, sweaty palms of hand, sweaty feet, Insomnia/Has not been able to sleep for weeks, may be about to get about 2 hours of sleep at maximum. On an unknown date, after starting treatment with AFLURIA the patient experienced Affecting his daily life. He had been to the primary care doctor, a psychiatrist, emergency room and crisis center but nothing was working. Adverse reaction persisted to date (at the time of reporting). For relevant test results see appropriate report section. Please add other relevant tests results manually as appropriate. Reporter's assessment: non-serious.
Expired Bexsero administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number AVXB59AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 4th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-OCT-2022 Reporter's Comment: the healthcare professional administered expired Bexsero dose to a patient. Reporter did not consent to follow up. Additional supportive information: A patient was administered with expired Bexsero dose which led to expired vaccine used.
10 epistaxis in the course of one month. Abnormal for myself. No other side effects I feel generally well.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 3:28 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 3:28 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 37.31.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM temperature was 34 total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively,8 AM: not provided, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.