chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Only received the first dose on 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows:  The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. No adverse events were was reported. No patient identifiers were provided. No lot number, expiration date and no vaccination date were provided. The reporter did not consent to follow up.
1/9 It started with upper arm and shin rash that was red, raised, and itchy.  At that point called my PCP and was advised over the phone to wait it out. Advised to keep hydrated and started using hydrocortisone cream. Opted to get a CoVid test because of the rash, chest congestion, and body ache.  Rash lasted for 5-6 days and has not returned. The other symptoms subsided as well. No additional issues and I am fully recovered.
Fever Blisters broke out on face; This case was reported by a consumer via call center representative and described the occurrence of fever blister in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th December 2019, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever blister. On an unknown date, the outcome of the fever blister was unknown.   It was unknown if the reporter considered the fever blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, had fever blisters which broke out on face, around bottom lips after vaccination with dose of Shingrix. The patient asked, if could take Valtrex. The reporter did not consented to follow up
REACTIVE ANGIOENDOTHELIOMATOSIS RASH; This spontaneous report received from a physician concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced reactive angioendotheliomatosis rash. Laboratory data (dates unspecified) included: Biopsy (NR: not provided) angioendotheliomatosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of reactive angioendotheliomatosis rash was not reported. This report was non-serious.
Hives various sites over arms, legs, some face. Pt given antihistamines for itching hives.
Developed SX of cough, congestion 8/30/22- tested positive for Covid on Abbott ID Now molecular test- has had known community exposure.
Immediately upon administering the vaccine, the patient's arm turned quite red. Within seconds, a small one inch wheal/hive developed at the site of injection. There was no respiratory involvement or systemic reactions. The patient was observed for 20 minutes. The reaction appeared to be resolving spontaneously. Follow up information from a RN indicated that the injection site wheal "resolved spontaneously". It was noted that 5 weeks post-onset, the patient had a similar reaction to  MMR.
Patient noticed redness and swelling at the site of vaccination, one day after the vaccine was administered. No treatment necessary as the swelling and redness have reduced.
Narrative:  Hospitalization: COVID-19 fully vaccinated, COVID-19 positive upon admission for edema due to suspected acute decompensated HF
tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported. Patient has it every day to varying degrees and It's more prominent when the patient is idle.   This case was linked to MOD-2021-287685 (Patient Link).
An hour after taking the vaccine she started having a mental fogginess, she had difficulty forming words.  About 4hrs later she had severe arm pain where she couldn't lift her arm. 8 to 10 hrs later she started to get a racing heart rate and shortness of breath. She developed severe post neck pain that radiate to the top of her head. She had nausea and a linger in her throat. She went to the ER on Nov 3rd.
pt recvd vax; lab tests w/in 24 hrs of vax revealed pos hepatitis b antigen;
The day after the vaccine (Sunday, 3/21/21), I had severe leg pain--throbbing in both legs.  My legs felt warm to the touch.   I also had a severe headache all day and a feeling of disorientation like I couldn't focus or concentrate.  I felt light-headed and very tired.  There was swelling, redness, and pain at the injection site (my left arm) all the way down the left side of my body (under my arm and around my ribs).  I took Acetaminophen, but the pain persisted all day.  The pain in my legs was the worst symptom and it was so painful and uncomfortable that it was impossible to sleep that night.  I've never felt anything like it. I was planning to go to an emergency clinic the next day if the pain continued.  I finally got to sleep in the morning  (Monday, 3/22/21) and slept for several hours.  When I woke up later that day (3/22/21), the pain was gone and I felt normal again.   I was still tired for the rest of the week and I continued to have swelling in my arm at the injection site, but otherwise, no other symptoms.  It took approximately 6 days for the pain and swelling in my arm to feel better.  I did not seek medical attention because the leg pain was gone within 24 hours, but I am concerned now and am wondering if there has been any permanent damage to my circulatory system or heart.  I have noticed that my pulse has been elevated for the last 3 weeks (as compared to normal).
A report has been received from a Pharmacist concerning a 5 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on an unknown date. Reporter stated that we inadvertently administered expired FLUMIST quadrivalent to a patient. The outcome of the event of inadvertently administered expired FLUMIST quadrivalent to a patient is unknown. The report was considered to be non-serious.
On Wednesday July 20, 2022, my symptoms were coughing, sneezing, runny nose and body aches  The following day I had a low grade fever.  On the 20th we went to the pharmacy to get our COVID-19 test and it was positive.  On Friday I reached out to my doctor but was only able to talk to PA and she said I didn't qualify for Paxlovid.  She did prescribed Benzonatate for my cough.  As of today, July 25th, I am coughing less than I was and I have some body aches.  My ribs are really sore from so much coughing.
Patient received vaccines, nurse left room, Dad came out of room stating child was seizing. Patient seized x2. Diastat administered by Dr. Patient then seized 1 more time. Patient transported to hospital via ambulance.
pt exp macular papular rash under breasts, covering stomach & on anterior thighs;rash sometimes itchy & sometimes painful;tx w/hydrocortisone & Zyrtec;
Pt is a 6 yo girl with asthma who developed fever and slight rash 5 days after receiving flu shot. No resp distress or edema. Rash described on erythematous papular over the lower extremities and trunk. Pt was reported to be ICL with URI symptoms at the time of receiving the flu shot.
Information has been received from a pharmacist who was told by a physician about a patient who was vaccianted with a dose of rubella virus vaccine live and mumps virus vaccine live and then was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Subsequently, following the dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live the patient experienced temporary paralysis. It was not reported if medical attention was sought. No outcome was reported. No product quality complaint was involved. Follow up information was obtained on 5/25/2006 indication that the pharmacist had no additional information regarding this case and could not provide physician information. Up internal review, temporary paralysis was determined to be an other important medical event (OMIC). Additional information is not expected.
Received call from mother 12/16/09 stating both legs very red at injection sites and sore.  Advised to see family physician or ER.
pt recv vax 20NOV96 & became pregnant;conception was estimated to have occurred two days prior to vax;MD noted in follow up that pt was being followed by infertility specialist;pt had positive beta strep cervical cult for premature labor;
Within 24 hours she developed diarrhea and nausea, fatigue, body aches, what she describes as cranial pressure, shortness of breath, episodes of lightheadedness with standing. She reported to the ED with dyspnea.
Developed Polymyalgia Rhuematica and Giant Cell Arteritis after second Pfizer vaccine.  Never had this condition or any symptoms related to them before.
Injection site lump, itchiness, soreness, redness 1 week after injection
Administration of vaccine past published expiry; The vaccine was thawed before the administration throughout the end of March to the beginning of April.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) and PRODUCT STORAGE ERROR (The vaccine was thawed before the administration throughout the end of March to the beginning of April.) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) and PRODUCT STORAGE ERROR (The vaccine was thawed before the administration throughout the end of March to the beginning of April.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) and PRODUCT STORAGE ERROR (The vaccine was thawed before the administration throughout the end of March to the beginning of April.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported  that 19 doses were administered to 19 patients on 29 Mar 2022, 30 Mar 2022, 31 Mar 2022, 01 Apr 2022 and 04 Apr 2022.The vail was initially stored in the refrigerator on 01-Apr-2022 and thawed on the day of use. The vial didn't undergo any temperature excursion.  No treatment medications was reported.
pt recvd vax  & mom noticed pt shaking, became limp & mother also noticed cyanosis on the face; pt adm to hosp for observation
SEVERE SCIATICA; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included sciatica. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced severe sciatica. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe sciatica. This report was non-serious.
26Dec2022 mild symptom and positive test 27Dec2022; 26Dec2022 mild symptom and positive test 27Dec2022; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 60-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GJ6742) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications: Other vaccine in four weeks was reported", vaccination date on 15Sep2022, lot number: 942381.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Dec2022, outcome "unknown" and all described as "26Dec2022 mild symptom and positive test 27Dec2022". The events "26dec2022 mild symptom and positive test 27dec2022" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, treatment included PAXLOVID.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5),  to the events  drug ineffective (LOE) and covid-19 cannot be ruled out.
Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine; No adverse event; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Prior to knowing that the vaccines which underwent a temperature excursion in the freezer were viable 131 patients received doses of the vaccine).    No concomitant information was reported. Reporter called to discuss a temperature excursion that occurred several days ago in the Freezer. Patient received vaccine from vaccine that underwent a temperature excursion in the Freezer. It was found out about the excursion in an audit. No adverse event reported. No treatment information was reported.
1st dose Jun2022, did not complete the series; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 22nd June 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 16-FEB-2023 Reporter's Comment: The certified pharmacy technician reported that the patient did not return for the rest of the series of the Twinrix. The reporter consented to follow up by postal. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Twinrix, which led to incomplete course of vaccination. This case was linked with US2023026721 which was reported by same reporter.; Sender's Comments:  US-GSK-US2023026721:Same reporter.
Fever, sight of vaccine (right deltoid) sore 1/29 onset. 1/31/13 admit to hospital. 1/31/13 wbc=28.5 with left shift.
First Covid shot received 01/20/21 caused hospitalization within 14 days for extreme A-Fib heartbeat. Fifth booster shot listed above caused similar irregular heartbeat problems that persist today.
COVID-19 BREAKTHROUGH: The patient presents with cough, fever, change in regular mentation. 84 y/o F with a PMHx of Alzheimer's disease and dementia presents to the ED brought in by her granddaughter with daughter at bedside c/o cough, fever, and change in regular mentation with an onset PTA. Pt hx is limited due to clinical condition. Pt's granddaughter states that the pt has been acting more confused than usual. In the room pt is combative and refusing to let nursing staff and provider touch her.  The course/duration of symptoms is unknown. The degree at onset was un
This spontaneous case reported by a consumer, describes the occurrence of product administered to patient of inappropriate age (14-year-old son given the Moderna vaccine by mistake) in a male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, product administered to patient of inappropriate age (14-year-old son given the Moderna vaccine by mistake). At the time of the report, product administered to patient of inappropriate age (14-year-old son given the Moderna vaccine by mistake) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
p/vax pt devel onset of vomiting-12hr duration;no fever (vomited several times) no other sx of illness;later vomited forcefully x 1;loss of blink reflux, rt eye & loss of facial expression;movement rt side office;dx Bells palsy;diff swallow
Urticaria, Hives, Puritis, Cough, Wheezing, Rhinitis, Throat tightness, Hoarse voice, Shortness of breath within 15 of Moderna booster injection despite premedication with Prednisone 10mg, Diphenhydramine 50mg, Pepcid 20mg; and Epi 0.3IM at time of vaccination. Puritis persisted after Solumedrol 80mg IV at ER. Mild cutaneous symptoms  waxed and waned over the next 15 hours. 16 hours post vaccination pt rapidly developed skin flushing, intense global puritis, hives, wheezing, dizziness, cough, facial swelling (eyelids, lips, ear), and diarrhea. Pt took Diphenhydramine 50mg, Pepcid 20mg, and Epi 0.3mg IM, symptoms resolved. At 17 hours post vaccination global puritis and skin flushing returned and continues to wax and wane, periods of coughing and rhinitis and itchy eyes keep occurring and resolving
Itching continued on my face, palms, head, back and scalp then it went to my arm. Then it went to my torso and my boobs all this happened with the first dose and it never went away and continued to the second dose and it didn't go away and here we are at the booster I got a rash from head to toe my literally entire body, my private areas, shoulders, neck, my arms, my thighs. It keeps getting progressively worse my eyes my lips mouth. They are large red itchy spots dry up and sometimes it bleeds depending on how dry it gets or how much I scratch.
-significant muscle pain (all over body), started about 1 day after administration and lasted about 15 days, ibuprofen taken to help with the pain and improve mobility -moderate fatigue, started about 1 day after administration and lasted a few days
woke up wet; her heart felt like her heart was going to burst out of her chest,beating very rapidly where she could hear it in her ears; beating very rapidly where she could hear it in her ears; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (woke up wet), HEART RATE INCREASED (her heart felt like her heart was going to burst out of her chest,beating very rapidly where she could hear it in her ears) and TINNITUS (beating very rapidly where she could hear it in her ears) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (woke up wet), HEART RATE INCREASED (her heart felt like her heart was going to burst out of her chest,beating very rapidly where she could hear it in her ears) and TINNITUS (beating very rapidly where she could hear it in her ears). At the time of the report, HYPERHIDROSIS (woke up wet), HEART RATE INCREASED (her heart felt like her heart was going to burst out of her chest,beating very rapidly where she could hear it in her ears) and TINNITUS (beating very rapidly where she could hear it in her ears) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.
lots of fatigue, neck and shoulder stiffness then sore ankle joints  and more pain in knees than uasual. now over the last month and a half scince the shot i am having  severe knee joint flare ups that are becoming more frequent. i have tried ice packs , heat. and i have an infrared sauna that usually helps and taking extra advils with no results.  the only thing i have done different is had the shots. this something you are seeing in people my age. iam nomally very active and this is becoming  very frustrating. do you have any suggestions