chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered pediatric vaccine to adult patient; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administered pediatric vaccine to adult patient) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    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 WRONG PRODUCT ADMINISTERED (Administered pediatric vaccine to adult patient) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administered pediatric vaccine to adult patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Administered pediatric vaccine to adult patient).    No concomitant medication was reported.    No treatment information was reported.
Beginning on the 17th, symptoms included extreme fatigue, deep chest cough (dry/non-productive), chills, body aches, headaches, and some congestion.  Aside from the cough the symptoms had mostly cleared up by the 24th but the cough lingered until the 1st.
reaction / rash on lower back; were very itchy; 12 to 15 noticeable welts; This case was reported by a consumer via call center representative and described the occurrence of rash in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd September 2022, the patient received the 1st dose of Shingrix (intramuscular). On 23rd September 2022, 1 days after receiving Shingrix, the patient experienced rash, itchy rash and welts. The patient was treated with loratadine (Claritine) and clarithromycin (Claritin Tablets (Clarithromycin)). On an unknown date, the outcome of the rash, itchy rash and welts were recovered/resolved.   It was unknown if the reporter considered the rash, itchy rash and welts to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's Comment: The reporter stated that the patient got the 1st dose of Shingrix Vaccine.  The Reporter stated that he got the vaccine in the left arm.  The reporter mentioned next day in the morning the patient  had a reaction.  The patient  had a breakout rash on my lower back and rash had 12 to 15 noticeable welts that were very itchy. The reporter state that the patient went to a dermatologist that prescribed Claritin tablets and a cream for the rash.  The reporter mentioned that the itching resolved after 8 to 9 days.   The patient reports that after treating the rash with Claritin and the cream, the rash had subsided.  The Patient reports the rash has disappeared and healed. The reporter give consent to follow up.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received SHINGRIX for prophylaxis. On 19th July 2018, the patient received the 1st dose of SHINGRIX. On 20th July 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm, chills and fever. On an unknown date, the outcome of the pain in arm, chills and fever were recovered/resolved. It was unknown if the reporter considered the pain in arm, chills and fever to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a sore arm the next day, which resolved after 4 days. The patient experienced chills and fever which lasted about 2 and a half days. The reporter did not consent to follow up.
Syncope/ episodes of syncope; although his heart has a normal rhythm, it slows down and then pauses; This is a spontaneous report received from a contactable reporter (physician) from the Medical Information Team.  A 45-year-old male patient received BNT162b2 (BNT162B2), in 2021 as DOSE NUMBER UNKNOWN, SINGLE (batch/lot number: unknown) for COVID-19 immunization; COVID-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Nov2021 as DOSE NUMBER UNKNOWN (BOOSTER), SINGLE (batch/lot number: unknown) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant), outcome "unknown" described as "Syncope/ episodes of syncope"; SINUS ARRHYTHMIA (non-serious), outcome "unknown" described as "although his heart has a normal rhythm, it slows down and then pauses." The patient underwent the following laboratory tests and procedures: Electrocardiogram ambulatory: heart has normal rhythm, notes: holter monitor showed that although his heart has a normal rhythm it slows down and then pauses; Magnetic resonance imaging: unknown results.  Additional information: The reporter (physician in (Withheld) dermatology) reported that her husband, an otherwise healthy male was vaccinated with the Pfizer vaccine in 2021 and received a booster from Moderna in Nov2021. 2 months later he has started having episodes of syncope. A holter monitor showed that although his heart has a normal rhythm, it slows down and then pauses. "MRI nl." There are cases of this phenomenon as a result of the vaccine. The reporter asked for more evidence of this and outcomes.   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely 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.
During quality control, it was discovered that vaccine was taken from -70 freezer and then moved and stored to a -20 freezer until immediately thawed and administered to patient.  This was reported to Pfizer, and found to be a supported excursion.
Reaction within 10 minutes. Felt dizzy/woozy, rapidly elevated blood pressure, and palpitations. Fatigue. Brief disoriented feeling. Elevated BP has continued. Sought medical attention on 1/21/22, die to ongoing SXS, and new headache/vision changes.
large, oval shape area around the injection site that is swollen; large, oval shape area around the injection site that is red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (large, oval shape area around the injection site that is swollen) and INJECTION SITE ERYTHEMA (large, oval shape area around the injection site that is red) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced INJECTION SITE SWELLING (large, oval shape area around the injection site that is swollen) and INJECTION SITE ERYTHEMA (large, oval shape area around the injection site that is red). At the time of the report, INJECTION SITE SWELLING (large, oval shape area around the injection site that is swollen) and INJECTION SITE ERYTHEMA (large, oval shape area around the injection site that is red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
I experienced a severe migraine, and around 2-3 AM I woke up with a racing heart rate (over 200bpm per my Garmin watch). I could barely stand and was nauseous. I called my nephew to take me to the ER. In the ER, they gave me IV medicine for Migraines. I was discharged after a few hours and rested when I got home. I still had a slight headache when I woke up, but it was better than before. It lasted the rest of the day then was gone the next.
Raised, itchy, red, splotchy rash to bilateral arms, chest, neck, stomach. Began day after vaccine. Recently changed soap and lotion around the time she took vaccine.
Moderate anaphylactic response - throat closing, tightness in chest. No history of anaphylactic response to vaccines BUT I do have a history with bee stings, sulfa drugs, and the the initial allergy shot from a new, stronger vial. Symptoms remained moderate - I didn?t treat with my epi pen, and eventually took Benadryl and was ok.
Pains; Headache; Discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 20Jan2022 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Jan2022, outcome "not recovered", described as "Pains"; HEADACHE (non-serious) with onset Jan2022, outcome "not recovered", described as "Headache"; DISCOMFORT (non-serious) with onset Jan2022, outcome "not recovered", described as "Discomfort".  Additional information: Reporter wanted recommendations because yesterday she received her first dose of the Pfizer COVID-19 Vaccine and she's experiencing some pains and a headache. So, she wanted to know if she could take Ibuprofen for her discomfort, Disclaimer provided, responded per attached document: Talk to a doctor about taking over-the-counter medicine, such as ibuprofen, acetaminophen, aspirin (only for people aged 18 or older), or antihistamines for any pain and discomfort experienced after getting vaccinated. Referred caller to HCP for further guidance, this report is not related to study or programmed, Reporter declined to complete a report, additional details and clarifications unable to be obtained.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initially just had moderate pain at injection site. Anything rubbing up against it was painful. Lasted at least a week. I do not know when it started but at some point I noticed that at the site of the injection there was an area about the size of a dime where all the pigment in my skin was gone. (I normally have alot of freckles). There is now a white filled in circle on my arm. This area will not even tan or burn when I am in the sun. This is concerning and I am wondering if I should get the second shot or not.
Rash and welts to the back, arms, scalp, chest thighs and ankles. Internal itching and burning sensation to  he skin
Information has been received from a public health nurse concerning an 11 year old female patient who was vaccinated with a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The nurse reported that the patient may have mumps. Additional information has been requested.
This spontaneous report as received from a nurse practitioner via healthcare worker refers to a multiple unspecified patients of unknown demographics. On an unknown dates the patient received improperly stored PNEUMOVAX 23 lot # L014458 with expiration date 11-FEB-2017; (strength, dose number, dose and route was not reported). Concomitant medication was not reported. No adverse effect was reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a lawyer and described the occurrence of neurologic injuries in a 33 year old male patient who received Lyme disease vaccine recombinant injection for prophylaxis. A physician or other healthcare professional has not verified this report. On an unspecified date, the patient experienced neurological injuries resulting in vision loss, short term memory loss, inability to walk, severe joint pain, fatigue, and permanent disability. Time to onset, treatment, and outcome were not reported. Per follow up report received on 03/21/2005:  Legal case, follow up not available.
So I didn?t know I was pregnant when I receive both my vaccinations. Ever since I have received them I?ve been nothing but sick starting in May I?ve had a upper respiratory infection and then it would go away out of the blue. In July I had a upper respiratory infection and then they told me it was a sinus infection RSV and an ear infection. I have never been sick like this I?m currently 32 to 33 weeks pregnant and I have again in upper respiratory infection. I finally have gotten azithromycin to help and it is done nothing I feel like someone is stabbing me in my ribs and in my shoulder blades. I have never been this sick. I?m starting to believe that after this vaccination it has messed with my immune system which is causing me to get recurrent Sickness
Mother states approx 2 hours after receiving vaccine, child developed rash to arms, face upper trunk and neck. Itchy.  Mom denies SOB.
Fever, knot/nodule at injection site, swollen hands and feet, rash on hands, feet, wrists.
Swelling to upper arm and axilla to arm vaccination was administered, occurred within 24hours.  Pain and sweling to axilla increase over next 48 hours.  Ibuprofen for pain with moderate relief.  Pain decreased from 6/10 to 4/10.
Swelling of wrists; Mobility decreased; Redness; Shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), JOINT SWELLING (Swelling of wrists), MOBILITY DECREASED (Mobility decreased) and ARTHRALGIA (Shoulder pain) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011AC1A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (Shoulder pain). On 16-Mar-2021, the patient experienced ERYTHEMA (Redness). On an unknown date, the patient experienced JOINT SWELLING (Swelling of wrists) and MOBILITY DECREASED (Mobility decreased). At the time of the report, ERYTHEMA (Redness) and ARTHRALGIA (Shoulder pain) had resolved and JOINT SWELLING (Swelling of wrists) and MOBILITY DECREASED (Mobility decreased) outcome was unknown.            No relevant concomitant medications were reported.  Treatment included cold compress.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Significant Follow-up received , outcome of the events erythema and pain in shoulder updated from unknown to recovered and new events are added.
My child broke out in horrible hives all over her body. We treated with benadryll and hydrocortisone cream at first, then had to treat with steroids after it still wouldn't clear up. The steroids finally made the hives go away. The hives and treatment lasted about two weeks, from the first break out.
Pt was inadvertently  given the first dose of the Moderna vaccine today. The Pt and father was informed.  Pt was monitored after administration with no reaction noted. Pt denies being in any distress, questions, concerns or needs. The Pt's father was present and notified. The father denies being upset, questions, concerns or needs. Pt and father verbalized understanding.
Narrative: Patient had a previous COVID-19 positive test on 3/19/2021. Patient received his first COVID-19 vaccination dose on 5/21/2021. One day post-vaccination (5/22/2021), patient reported shakes and chills. On 5/24/2021, patient reported he no longer had fevers or body aches but endorsed shortness of breath with occasional wheezing and chest tightness in addition to 6/10 injection site tenderness. Patient denied facial lip or tongue swelling. Patient seen in the emergency room and tested positive for COVID-19 on 5/24/2021; however, test result may likely be residual from prior COVID-19 test given first vaccination was given within 90 days of prior infection.
Dizziness x 1 month, visual changes only for a few seconds, difficulty ambulating for few seconds.
Very enlarged Lymph nodes in neck. Today is 13 weeks after 2nd vaccine and still very enlarged.
Patient, 7/5/1992 received his second dose of Pfizer. During observation the patient had a syncopal episode as he was being observed in his car. Observation staff member witnessed the patient?s eyes roll to the back of his head and pass out for approximately 30 seconds. EMS was called. Patient awoke and was able to walk to the observation tent where the first set of vitals was taken. Once EMS arrived at 1514, they completed an assessment and continued to monitor the patient. Vitals were taken as follows:  1504- 120/70 HR 69 RR 20 O2 97  1515- 98/58 HR 64 RR 16 O2 98  1530 -120/80 HR 70 RR 16 O2 97 BGL 108  1545-120/80 HR 68 RR 17 O2 99  Patient was provided with juice and crackers, and was observed for an extensive period of time with EMS. Patient declined transport to the hospital via EMS as he was alert and oriented x 3. Patient was advised to contact his PCP but he declined having one. RN instructed the patient to contact 911 if there is shortness of breath, difficulty breathing, and any other sign of distress
This spontaneous report was received from a registered nurse concerning an unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On 27-OCT-2016 (also reported as "after that date"), the patient were vaccinated with an unspecified number of doses of improperly stored of VARIVAX lot number M018436 expiration date: 13-FEB-2017 or L046888, expiration date; 23-NOV-2017 (strength, dose and route were not reported) for prophylaxis. It was reported that the sterile diluent (manufacturer unknown) did not undergo a temperature excursion. The temperature of excursion with VARIVAX was 6 to 14 Fahrenheit degrees during 5 hours. No previous temperature of excursion was performed. The temperature of excursion was detected by data logger. No adverse effects were reported. Sender's Comments: US-009507513-1709USA008679.
Patient with J+J vaccine 03/31/21 who admitted with sickle cell crisis who tested detected for COVID during admission.  Patient without respiratory issues during stay, was admitted for pain control.  Provider discharge summary below:    "61-year-old male with history of hemoglobin S and C disease, presented with sickle cell painful episode.  he was also found to have  COVID.   Brief Summary of Hospital Stay: Pain improved with IV analgesia. Other chronic medical issues remained stable. He will see hematology as opt in 8 days.   His COVID remained asymptomatic other than an initial fever, and he did not require eighty supplemental oxygen nor did he have any pulmonary compromise.  No therapy was therefore warranted.  He has been instructed on proper quarantine precautions to take at home.   Issues Requiring Follow Up: Hematology follow up in 2 days.   I would recommend that his outpatient providers consider outpatient COVID treatment given his risk factors.  Monoclonal antibody therapy may be available.  Otherwise please review imaging and labs as below:"
More than 35 days from first dose/ second shot has not been given yet; Wart on right wrist; This spontaneous case was reported by a consumer and describes the occurrence of SKIN PAPILLOMA (Wart on right wrist) and PRODUCT DOSE OMISSION ISSUE (More than 35 days from first dose/ second shot has not been given yet) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     Concurrent medical conditions included Clotting disorder. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Clotting disorder.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced SKIN PAPILLOMA (Wart on right wrist). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days from first dose/ second shot has not been given yet). At the time of the report, SKIN PAPILLOMA (Wart on right wrist) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (More than 35 days from first dose/ second shot has not been given yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The historical vaccine Flu shot was reported and adverse event experienced was Wart.  No Treatment information was reported.
suspected vaccination failure; shingles; This case was reported by a consumer via social media interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and COVID-19 VACCINE for covid-19 prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine, the 2nd dose of Shingles vaccine and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received both the Shingles vaccine and still got shingles. The patient heard that shingles could be the side effect of Covid shots. It was unknown if the reporter considered the vaccination failure and shingles to be related to Covid-19 vaccine. This case was considered as suspected vaccination failure as details regarding, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Generalized urticaria and arthralgias, Swelling and itching to all extremities, Dx Stevens Johnson Syndrome  695.1  8/15/08 Reviewed PCP office records of 7/29/08. FINAL DX: erythema multiforme Records reveal patient experienced progressive rash x 4 days.  Rash raised & red, initially on arms then spreading to back & legs w/itching.  Started 2 days s/p vaccination.  Appetite decreased, felt chilled, itchy, difficulty breathing, joint & muscle pain.  Exam at that time revealed generalized wheals w/edema of both legs.  Tx w/steroids & close f/u.
02APR91 baby rec'd DTP/OPV/HIB vax mom reports no fever or problems p/vax but started w/temp last night; Mom did not know how high the fever was; Did not report any other problems;
Vaccine administered 10/8 - patients mom noticed redness, swelling, minor bruising at/near injection site on Friday 10/11. Patient was taken to walk-in. No meds administered - MD stated that it could be an insect bite or an insect bite reaction to flu shot. Mom stated patients arm returned to normal within 1 day after applying ice.
Next day headaches and lower back pain - still experiencing both today.  Ibuprofen helps with headache sort of but not lower back pain