chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gastrointestinal? Bleeding; This is a spontaneous report from a contactable consumer (Patient's sister) via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # UNKNOWN:), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received the first dose already and then had a GI (gastrointestinal)  bleeding. The clinical outcome of gastrointestinal bleeding was unknown.  Information about lot number has been requested.
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 36-year-old female 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 10:46 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 10:46 AM, 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 36.13 . Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 9 AM, temperature was 34 respectively, 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, 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 Fisher 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.
april 3 hyperacusis april 8 hyperacusis amplified to inability to work and tinnitus started.   disorientation feelings.  no sleep possible. no sound masking possible. tinnitus was louder than two sound machines on FULL volume.  april 13. GP prescribes claritin, flonase (double dose), neomycin drops april 18 brain on fire with headache, pain april 19 ENT did blood work, visual and hearing tests. stopped flonase. started azelastine.  april 26. started to hear crackling in right ear april 27 soreness below right ear  may 2 SETBACK almost a panic attack (I assume) hyperacusis returned but not as severe as before.  may 3 new ENT restarted flonase (double dose) may 6 brain on fire again. reduced flonase to normal dose.  may 10 rock hard lymph node right side below ear. feeling better on lower flonase.   may 11 lesser panic attack. lesser hyperacusis reaction.  may 13 given doxycyclene 7 days june 3 slept without sound machine 8 weeks in
rebound COVID, horrific taste in mouth entire course of treatment; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (rebound COVID, horrific taste in mouth entire course of treatment) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 003C21A and 031B21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Depression and Allergy. Concomitant products included LAMOTRIGINE, SERTRALINE and TRAZODONE for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (rebound COVID, horrific taste in mouth entire course of treatment). At the time of the report, COVID-19 (rebound COVID, horrific taste in mouth entire course of treatment) had not resolved.            Company comment: This spontaneous case concerns a 55 year old female patient with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, unknown days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the previous two doses with mRNA-1273 vaccine in accordance with the recommended schedule, the last dose being given about 8 months prior to the third dose, with no reported adverse events. The patient reported rebound COVID-19, 3 days after cessation of treatment with Paxlovid for COVID-19. The event was not resolved. The ongoing COVID-19 pandemic could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-573531 (Patient Link).; Sender's Comments: This spontaneous case concerns a 55 year old female patient with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, unknown days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the previous two doses with mRNA-1273 vaccine in accordance with the recommended schedule, the last dose being given about 8 months prior to the third dose, with no reported adverse events. The patient reported rebound COVID-19, 3 days after cessation of treatment with Paxlovid for COVID-19. The event was not resolved. The ongoing COVID-19 pandemic could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient felt weak and lightheaded immediately after receiving vaccine Heart Rate increased to 122 BPM. BP 180/80. Other vital signs normal After 45m obs v/s HR 96 O2 98% room air, PB 110/60. Patient stated she felt she felt too sick for discharge home and requested EMS be called. EMS responded and xported to hosp
Patient began complaining of feeling flushed and high HR 127 and high BP 167/100 30 minutes after receiving vaccine. Stated she had been having this issue intermittently since her second covid vaccine dose. Stated she was anxious and sob. Was taken to ER and then later that night at 2330 she went to ER for the same symptoms where "she got a shot in her butt to calm her down" She is seeing her PMD 2/14/22 at 1530.
Hospitalized 6/8/22-6/9/22 Hypoxia, headache, cough, sore throat, malaise, dyspnea, fever, O2 supplement, elevated d-dimer,  respiratory failure
hives; This case was reported by a physician via sales rep and described the occurrence of hives in a male patient who received Men B NVS (Bexsero) 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 11th March 2021, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 12th March 2021, 1 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   The reporter considered the hives to be possibly related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age group not reported but as per birth year patient could be adolescent or adult. The age at vaccination was not reported, but it could be 17 or 18 years. The patient developed hives morning after the vaccine was given. The reporter thought it was related to the vaccine administered. The reporter consented to follow up.
missed second dose; a rash starting from his back that spread to his whole body; it is still itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (it is still itching), PRODUCT DOSE OMISSION ISSUE (missed second dose) and RASH (a rash starting from his back that spread to his whole body) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL S) from 11-Jan-2021 to an unknown date for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced PRURITUS (it is still itching) and RASH (a rash starting from his back that spread to his whole body). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed second dose). The patient was treated with TRIAMCINOLONE for Itch, at a dose of 1 dosage form. At the time of the report, PRURITUS (it is still itching), PRODUCT DOSE OMISSION ISSUE (missed second dose) and RASH (a rash starting from his back that spread to his whole body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details also included Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Significant follow-up received on 23-Jun-2021 where events has been updated as Remanence of rash and Missed second dose
This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 58-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included high blood pressure. On 23rd March 2018 17:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 24th March 2018, 1 days after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. On 25th March 2018, the patient experienced injection site itching, injection site blisters and diarrhea. On an unknown date, the patient experienced nerve pain, injection site hyperesthesia and injection site pain. The patient was treated with gabapentin, MOTRIN and medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the nerve pain, injection site hyperesthesia and injection site pain were not recovered/not resolved and the outcome of the injection site itching, injection site erythema, injection site blisters, injection site swelling and diarrhea were recovered/resolved. The reporter considered the nerve pain, injection site itching, injection site hyperesthesia, injection site erythema, injection site blisters, injection site swelling, diarrhea and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient was receiving blood pressure medication. The patient was administered SHINGRIX in the left arm. On 24th March 2018, one day after receiving vaccination, the patient developed a big orange size circle on her upper left arm, which was very red, raised and swollen. On 25th March 2018, 2 days after receiving vaccination, the patient also developed itching in the area along with tiny red blisters and diarrhea. The patient's arm was very sensitive to touch and was very painful. The swelling in the area lasted for about 7 to 10 days. The redness went down after two and half weeks. The red blisters went away after 2 to 3 days. The itchiness and diarrhea lasted for total of 2 to 3 days. The patient had still not recovered from the pain and sensitivity to touch. The patient stated she visited her doctor office sometimes in the end of April to follow up with her health care physician. The patient take MOTRIN for pain and use hot pack or ice pack as needed in the area. The patient was referred to her Neurologist, which she visited on 7th June 2018. The patient neurologist had recommended her to see allergist and dermatologist to see if there was anything underlying from the vaccine that was adding to the pain she was experiencing.
VZV given on 9/20/11 - next day red, swelling (L) posterior arm with increased redness, induration 9/22/11. Hot to touch, itching approx size 2x2.
The day after my 2nd Moderna dose,  my left arm (site of injection) developed a red rash. The site was already painful about 8 hrs after the injection.
Dizziness to the point she could hardly walk from her bed to the bathroom; Weakness; Could hardly focus her eyes; Could not read or watch TV; It hurt to touch her skin (hand, arm, face); Slight nausea; Body aches; chills; fatigue; Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness to the point she could hardly walk from her bed to the bathroom), ASTHENIA (Weakness), OCULAR DISCOMFORT (Could hardly focus her eyes) and VISUAL IMPAIRMENT (Could not read or watch TV) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). On 30-Mar-2021, the patient experienced DIZZINESS (Dizziness to the point she could hardly walk from her bed to the bathroom), ASTHENIA (Weakness), OCULAR DISCOMFORT (Could hardly focus her eyes), VISUAL IMPAIRMENT (Could not read or watch TV), PAIN OF SKIN (It hurt to touch her skin (hand, arm, face)), NAUSEA (Slight nausea), MYALGIA (Body aches), CHILLS (chills) and FATIGUE (fatigue). On 01-Apr-2021, PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness to the point she could hardly walk from her bed to the bathroom), ASTHENIA (Weakness), OCULAR DISCOMFORT (Could hardly focus her eyes), VISUAL IMPAIRMENT (Could not read or watch TV), PAIN OF SKIN (It hurt to touch her skin (hand, arm, face)), NAUSEA (Slight nausea), MYALGIA (Body aches), CHILLS (chills), FATIGUE (fatigue) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
COVID+ 11/11/22 - Vaccination status - moderna x3   BRIEF OVERVIEW: Discharge Provider: DO Primary Care Provider at Discharge: MD Admission Date: 11/11/2022 Discharge Date: 11/13/2022    Active Hospital Problems   Diagnosis Date Noted POA ? COVID 11/11/2022 Yes ? Chronic systolic heart failure (HCC) 11/11/2022 Yes ? History of atrial fibrillation 05/04/2020 Yes ? Anxiety and depression 12/03/2019 Yes ? Hyperlipidemia 10/02/2019 Yes ? BPH (benign prostatic hyperplasia) 10/02/2019 Yes ? Morbid obesity (HCC) 03/28/2018 Yes ? Type 2 diabetes mellitus with complication, without long-term current use of insulin (HCC) 03/28/2018 Yes   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypoxia  Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present (HCC) COVID-19   HOSPITAL COURSE: 73-year-old gentleman with known history of diabetes atrial fibrillation presents to the emergency department with worsening shortness of breath.  Patient also with increased cough.  Patient diagnosed with COVID-19 in the emergency department.  Patient had received his vaccinations up to the 1st booster.  Patient had a low-grade temperature tachycardic increased respiratory rate on presentation.  Oxygen saturations were 78% on room air.  Patient was placed on 3 L per nasal cannula admitted to the hospital.  He was given Decadron.  There was also some concerns about possible mild pulmonary edema on presentation.  CT angiogram was done coming in which did show bronchial wall thickening but no evidence of PE.     Over the next 2 days patient's respiratory status improved significantly.  He was able to be weaned from room air.  Patient was anxious for discharge to home.  Since his clinical conditions has stabilized going to be discharged home.   Of note patient had elevated blood sugars are hospitalization most likely 2nd to steroids.  His hemoglobin A1 c has increased to 11.2 from 9.8 prior.  Patient does admit to drinking regular soda pop frequently at home.  He also does not check his blood sugars.  Patient was previously on metformin but was unable to tolerate.  He states a caused him diarrhea.  He currently is on Actos.  We discussed that is Actos may be contributing to his lower extremity edema.  We also discussed that he should  follow-up with his primary care physician to discuss appropriate medications to start on as an outpatient.  Patient is hesitant to want to be taking insulin.   Patient also had cardiomegaly on CT scan.  Wife asked about a. Patient did have an echocardiogram ordered in August.  Both him and his wife for unaware that this was ordered.  They been encouraged to follow-up with primary care back to get a repeat echo done.   At the time of discharge all questions have been answered.  Of course of patient's worsening shortness of breath develops high fevers chills or feels his clinical condition is deteriorating anyway he should call his primary care physician or return to the emergency department immediately for further evaluation.
I have hypopigmentation in the shape of the bandage applied after vaccination. It has been more than 1 year. I have since used bandages without hypopigmentation.
little sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14-JUN-2023, the patient received Shingles vaccine. On 14-JUN-2023, less than a day after receiving Shingles vaccine, the patient experienced pain (Verbatim: little sore). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JUN-2023 The case was received from the patient via interactive digital media The patient got the vaccine on the day of reporting it was a little sore but all good.
Itching; Skin scarred; redness; Prickling/Tingling; Burnt looking; 2 blisters with clear liquid right under injection site; sore arm; great big rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE VESICLES (2 blisters with clear liquid right under injection site), PARAESTHESIA (Prickling/Tingling), PAIN IN EXTREMITY (sore arm), PRURITUS (Itching) and SCAR (Skin scarred) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 0D1A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sarcoidosis since 2000, Rheumatoid arthritis since 2010, Kidney enlargement (worse-discomfort) since 2000, Diabetic since 2010 and Drug allergy (Allergy to Levaquin for Swelling and , Sulphur drugs for itching). Concomitant products included PREDNISONE and LEFLUNOMIDE for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and RASH (great big rash). On 26-Feb-2021, the patient experienced VACCINATION SITE VESICLES (2 blisters with clear liquid right under injection site). On an unknown date, the patient experienced PARAESTHESIA (Prickling/Tingling), PRURITUS (Itching), SCAR (Skin scarred), ERYTHEMA (redness) and VACCINATION SITE PAIN (Burnt looking). The patient was treated with CORTISONE ongoing since an unknown date at a dose of 1 dosage form. On 03-Mar-2021, PAIN IN EXTREMITY (sore arm) outcome was unknown. At the time of the report, VACCINATION SITE VESICLES (2 blisters with clear liquid right under injection site) had not resolved and PARAESTHESIA (Prickling/Tingling), PRURITUS (Itching), SCAR (Skin scarred), ERYTHEMA (redness), RASH (great big rash) and VACCINATION SITE PAIN (Burnt looking) outcome was unknown.            Concomitant products included Prednisone 6mg, Vitamin c 100mg, , Leflunomide 20mg, , Vitamin D3 100mg, CoQ10 50mg, Zinc  Treatment drug include Cortisone OTC  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 22-Mar-2021: Significant FU - Pictures of events attached. On 10-May-2021: Non-Significant FU-Contact info updated. On 01-Jun-2021: Significant FU - Extra events updated. On 04-Jun-2021: Non-Significant FU- NNI
Lips swelling, itchiness, dryness, peeling and redness 2 weeks after vaccine, went to the doctor and was told to take a histamine for a few days and if it doesn?t improve to take a steroid.
Extreme ITP,  platelets <1,000, spontaneous bleeding, bruising, petechiae
Rash from injection site covering body, shortness of breath. Oral BENADRYL, IV BENADRYL, Nebulizer treatment.
patient was not given Bexsero but a different brand; This non-serious case was reported by a consumer via call center representative and described the occurrence of interchange of vaccine products in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number E74MY, expiry date 31-JUL-2024) for prophylaxis.   Co-suspect products included MENINGOCOCCAL B VACCINE (TRUMENBA) (batch number ER2621, expiry date DEC-2023) for prophylaxis.   On 02-JUN-2023, the patient received the 1st dose of Bexsero. On 05-JUL-2023, the patient received TRUMENBA. On an unknown date, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: patient was not given Bexsero but a different brand). The outcome of the interchange of vaccine products 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: 6-Jul-2023 The case was reported by the patient's parent. The patient was administered the vaccine at a local pharmacy. The reporter was told that the patient would be getting a 2nd dose in 30 days. Not all information was available. The reporter did not provide consent to follow-up with health care professional. The reporter did not consent to follow-up. The patient received a dose of Trumenba after Bexsero first dose, which led to interchange of vaccine products.