chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to the touch at the injection site), VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE WARMTH (hot to the touch at the injection site), VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, VACCINATION SITE WARMTH (hot to the touch at the injection site), VACCINATION SITE PRURITUS (itchy at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: No specific follow-up information recorded.
12/21/21 presents to EC ED for "level 2 trauma s/p MVA with rollover" "left chest and wrist pain". PMHx of "diabetes, hypertension, dyslipidemia"
loosing muscle were vaccine was injected; Indentation,huge indentation in upper arm, indentation is two fingers wide across the arm and loosing muscle were vaccine was injected; Itching; heat, injection site was hot to touch; Injection site puffy and swollen; Bump in the injection site; Redness; Dizziness; Like having a severe flu; Sick to stomach; Quarter size lump; Quarter size knot were had injection; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Like having a severe flu), ABDOMINAL DISCOMFORT (Sick to stomach) and PRURITUS (Itching) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced ERYTHEMA (Redness), DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Like having a severe flu), ABDOMINAL DISCOMFORT (Sick to stomach), INJECTION SITE WARMTH (heat, injection site was hot to touch), INJECTION SITE OEDEMA (Injection site puffy and swollen), INJECTION SITE MASS (Bump in the injection site), VACCINATION SITE MASS (Quarter size lump) and INJECTION SITE NODULE (Quarter size knot were had injection). In July 2021, the patient experienced PRURITUS (Itching) and INJECTION SITE INDENTATION (Indentation,huge indentation in upper arm, indentation is two fingers wide across the arm and loosing muscle were vaccine was injected). On an unknown date, the patient experienced INJECTION SITE ATROPHY (loosing muscle were vaccine was injected). On 23-Jun-2021, ERYTHEMA (Redness), DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Like having a severe flu), ABDOMINAL DISCOMFORT (Sick to stomach), INJECTION SITE WARMTH (heat, injection site was hot to touch), INJECTION SITE OEDEMA (Injection site puffy and swollen) and INJECTION SITE MASS (Bump in the injection site) had resolved. At the time of the report, PRURITUS (Itching), INJECTION SITE INDENTATION (Indentation,huge indentation in upper arm, indentation is two fingers wide across the arm and loosing muscle were vaccine was injected) and INJECTION SITE ATROPHY (loosing muscle were vaccine was injected) outcome was unknown, VACCINATION SITE MASS (Quarter size lump) had resolved with sequelae and INJECTION SITE NODULE (Quarter size knot were had injection) had resolved.            No concomitant medication information was provided.  Patient took a headache pill to treat symptoms.
patient experienced weakness; This serious case was reported by a physician via call center representative and described the occurrence of weakness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced weakness (Verbatim: patient experienced weakness) (serious criteria hospitalization). The outcome of the weakness was unknown.   It was unknown if the reporter considered the weakness to be related to Shingrix.     It was unknown if the company considered the weakness to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-OCT-2023 The healthcare professional stated that patient in her 50's had Shingrix (no date or site). The patient experienced weakness and was admitted to the hospital and now was still in a rehab center. The reporter consented to follow up. This case is linked with US2023144348, reported by same reporter.; Sender's Comments:  US-GSK-US2023144348:Patient 1 of 2
Headache; sensitivity to light; experience of nausea and dizziness and I still get that feeling now; experience of nausea and dizziness and I still get that feeling now; This is a spontaneous report from a Contactable consumer (patient, self-reporting). A patient of an unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN0181 and expiration date was not reported), dose 1 via an unspecified route of administration on 23Jun2021 as single dose for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. On June 23rd Patient took the first Pfizer COVID Vaccine now that week patient was fine but the week of 4Jul2021 and started getting strong headache some sensitivity to light and some experience of nausea and dizziness and still get that feeling now. Patient was supposed to have the 2nd vaccine last week but belated twice (Missed dose) because patient still feel those things, so do not know whether that's common after the first week. The outcome of the event was not recovered.  Follow-up (27Aug2021): Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100951226 similar report from same reporter
SICK AS A DOG; CAN'T GET OUT OF BED; SLEPT OVER A HUNDRED HOURS AND 6 DAYS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on 19-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAY-2021, the subject experienced sick as a dog. On MAY-2021, the subject experienced can't get out of bed. On MAY-2021, the subject experienced slept over a hundred hours and 6 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick as a dog, and the outcome of can't get out of bed and slept over a hundred hours and 6 days was not reported. This report was non-serious.
Chills, fever, headache, body ache, nausea, diarrhea
developed eczema on my left ring finger within a week of the second vaccination/eczema has continued to spread to my face, armpits, elbows, shoulders, vagina, leg, and all over my hands and wrists; developed eczema on my left ring finger within a week of the second vaccination/eczema has continued to spread to my face, armpits, elbows, shoulders, vagina, leg, and all over my hands and wrists; developed eczema on my left ring finger within a week of the second vaccination/eczema has continued to spread to my face, armpits, elbows, shoulders, vagina, leg, and all over my hands and wrists; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Sep2021 15:30 (Lot number: EW0167) at the age of 30 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ST. JOHN'S WORT. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0168, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 19Aug2021, when the patient was 29 years old, for COVID-19 Immunization.  The following information was reported: ECZEMA (non-serious), ECZEMA (non-serious), HAND DERMATITIS (non-serious) all with onset 15Sep2021 09:00, outcome "not recovered" and all described as "developed eczema on my left ring finger within a week of the second vaccination/eczema has continued to spread to my face, armpits, elbows, shoulders, vagina, leg, and all over my hands and wrists". The event "developed eczema on my left ring finger within a week of the second vaccination/eczema has continued to spread to my face, armpits, elbows, shoulders, vagina, leg, and all over my hands and wrists", "developed eczema on my left ring finger within a week of the second vaccination/eczema has continued to spread to my face, armpits, elbows, shoulders, vagina, leg, and all over my hands and wrists" and "developed eczema on my left ring finger within a week of the second vaccination/eczema has continued to spread to my face, armpits, elbows, shoulders, vagina, leg, and all over my hands and wrists" was evaluated at the physician office visit. Therapeutic measures were taken as a result of eczema, eczema, hand dermatitis.  Additional information: I developed eczema on my left ring finger within a week of the second vaccination. The eczema has continued to spread to my face, armpits, elbows, shoulders, vagina, leg, and all over my hands and wrists ever since the vaccination. I had to get topical corticosteroids to treat the eczema which temporarily helps, but has still not fully resolved the condition. I have never had eczema or any type of skin condition before in my life until I received the Pfizer COVID-19 vaccine.  Follow-up attempts are completed. No further information is expected.
VERY Severe neck pain and stiffness, injection site arm pain, sever headache, fatigue and body aches lasted 2 days
Received her first dose Pfizer vaccine (LOT#: EW0187 EXP: 8/2021) at 1519 on 6/01/21. Patient alerted EMT at 1535. Patient stated that she felt dizzy about 10 minutes after receiving the vaccine. PHN asked patient to stay an extra 30 minutes for observation. Patient agreed to stay. EMT assessed and took patient vital signs at 1540. BP: 111/65, pulse: 86, O2: 99%. Patient stated that she had not eaten anything before her vaccine. Patient was given a snack and water. Patient finished her snack and drank her water. EMT reassessed and retook patients vital signs at 1550. BP: 105/62, pulse: 85, O2: 99%. Patient stated that her symptoms had subsided. EMT reassessed and retook patients vital signs at 1600. BP: 100/65, pulse: 85, O2: 99%. Patient stated that she no longer had symptoms and did not want to stay the full 30 minutes anymore. Patient was educated on worsening signs and symptoms of the vaccine side effects and when to call EMS or go to the ED/urgent care. Patient verbalized understanding of education. PHN advised patient to stay her full 30 minutes and if she left she would be leaving AMA. Patient agreed and decided to leave vaccination site at 1603. Patient left vaccination site at 1603 unassisted and with a steady gait.
soreness of her arm is worse; tiredness is worse; This is a spontaneous report from a contactable consumer or other non-HCP. A female patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 16Apr2021 as single dose, Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 for COVID-19 immunization. It was reported that patient got 2nd dose yesterday, 16Apr2021 and wants to know if she can continue taking her vitamins since she did not take it yesterday. She also mentioned that the soreness of her arm and her tiredness is worse compare to what she experienced after her first dose. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
both of my arms are in excruciating pain; severe pressure in my chest; My heart is racing; short of breath; high fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (both of my arms are in excruciating pain), CHEST DISCOMFORT (severe pressure in my chest), PALPITATIONS (My heart is racing), DYSPNOEA (short of breath) and PYREXIA (high fever) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (both of my arms are in excruciating pain), CHEST DISCOMFORT (severe pressure in my chest), PALPITATIONS (My heart is racing), DYSPNOEA (short of breath), PYREXIA (high fever) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (both of my arms are in excruciating pain), CHEST DISCOMFORT (severe pressure in my chest), PALPITATIONS (My heart is racing), DYSPNOEA (short of breath), PYREXIA (high fever) and FATIGUE (fatigue) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Initial report received from a pharmacist on 22 Dec 2009: This patient received S-OIV FLUVIRIN (batch no. 102134P1) on 22 Dec 2009. The patient experienced numbness and tingling "across the body" after 3 hours of vaccination on 22 Dec 2009. The events were ongoing and final outcome of the events was reported as conditioned unchanged.
COVID-19; COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Nurse). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Nov2021 at 02:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 19Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Spleenectomy" (unspecified if ongoing). Known allergies were not reported. There were no concomitant medications received in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02May2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (30Apr2022) negative, notes: was negative then and for three days; (01May2022) negative; (02May2022) negative; (02May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient's husband tested positive on 30Apr2022 so she took a test, was negative then and for three days. On 02May2022 had Covid symptoms and tested positive. Mod severe symptoms. Called Health Dept. for Paxlovid and started on 07May2022. Symptoms diminishing until today 09May2022 and then return of symptom with nausea and diarrhoea and fatigue the worst. Paxlovid (lot number:GA1189), treatment start date: 23May2022, treatment stop date: 28May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
A report has been received from a Health Professional concerning a 3 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. Nurse reported that expired FLUMIST was administered to 3 patients. FLUMIST expired on 09-Mar-2016 and was administered on 11-Mar-2016. The outcome of the event of three patients received expired FLUMIST vaccine/FLUMIST expired on 09-MAR-2016 is unknown. The report was considered to be non-serious. The reporter considered that there was no causal relationship between three patients received expired FLUMIST vaccine/FLUMIST expired on 09-MAR-2016 and FLUMIST QUADRIVALENT.
A nurse is calling in to report an AE on an infant that received ROTATEQ as their first rotavirus vaccine and then received their second rotavirus vaccine dose as ROTARIX at another providers office. The nurse states that the infant is going to recei; No additional AE details were provided; This spontaneous report was received from a registered nurse, referring to an infant patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unknown date, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, vaccination scheme, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis, then received their second rotavirus vaccine dose as rotavirus vaccine live oral 1v (ROTARIX) at another providers office (interchange of vaccine products). The nurse stated that the infant was going to receive their third rotavirus vaccine dose as rotavirus vaccine, live, oral, pentavalent (ROTATEQ) to complete their series. No additional adverse event details were provided.
expired vial was moved from the freezer to the fridge on 29-Apr-2022; Vaccine was expired on 05-May-2022 and administered on 06-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 05-May-2022 and administered on 06-May-2022) and PRODUCT STORAGE ERROR (expired vial was moved from the freezer to the fridge on 29-Apr-2022) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 05-May-2022 and administered on 06-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (expired vial was moved from the freezer to the fridge on 29-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 05-May-2022 and administered on 06-May-2022) and PRODUCT STORAGE ERROR (expired vial was moved from the freezer to the fridge on 29-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial did not undergo any temperature excursions.  No concomitant medications were provided by the reporter.  It was reported that they have vaccinated only nine people with Moderna on 06-May-2022. They originally thought it was 10. Of those, all were boosters except one who had their second dose.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Follow-up contains non significant information. Narrative updated. On 11-May-2022: Significant Live follow-up appended-  verbatim of product storage error was updated. Date on which vial was removed from refrigeration updated
Chills, muscle aches, fever, lethargy, loss of appetite began at 12:30am and continued until 12:30 pm on 2-20-21
This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 59-year-old female patient who received SHINGRIX (batch number 32ZG4, expiry date 9th July 2021) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of swelling (1st dose received on an unknown date, for tolerance refer case US2019GSK037152). On 21st February 2019, the patient received the 2nd dose of SHINGRIX. On 21st February 2019, immediately after receiving SHINGRIX, the patient experienced injection site hemorrhage, contusion and injection site swelling. On an unknown date, the outcome of the injection site hemorrhage, contusion and injection site swelling were not recovered/not resolved. It was unknown if the reporter considered the injection site hemorrhage, contusion and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose of SHINGRIX on an unknown arm. The patient began swelling immediately following vaccination, directly under the injection site. The patient experienced purple bruising and bleeding down the arm described as not profusely, but dripped down the arm. The reporter noted bleeding resolved, and swelling had begun to go down.
Has been almost disabled for a year after receiving your booster; This spontaneous case was reported by a patient and describes the occurrence of DISABILITY (Has been almost disabled for a year after receiving your booster) in a 23-year-old patient of an unknown gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISABILITY (Has been almost disabled for a year after receiving your booster) (seriousness criteria disability and medically significant). At the time of the report, DISABILITY (Has been almost disabled for a year after receiving your booster) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  Company comment: This spontaneous case concerns a 23 year old patient of unknown gender, with no reported medical history, who experienced the unexpected serious (disability, medically significant) event of Disability, unknown time after receiving the booster dose with mRNA-1273 vaccine. It was reported that the patient had been almost disabled for a year after receiving the booster dose. No information on detailed clinical course and details pertaining to previous doses was available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Admitted with bilateral pulmonary emboli. Treated with anticoagulation via pulmonary catheter