chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bell's palsy; This is a spontaneous report from a contactable physician and consumer (receptionist). A 55-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 13Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccines received on four weeks. Patient was not pregnant. The patient experienced bell's palsy on Apr2021 which caused hospitalization. Prednisone was given as treatment. Outcome of the event was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of Bell's palsy due to temporal relationship and current known drug safety profile.  Case will be re-assessed upon the additional information provided. 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.
Left top quadrant of thoracic area has 4 round shaped red outbreaks smallest 1 cm & largest 4 cm diameter looking like ringworm marks.
1/11/21 started with needle like discomfort in left big toe while in bed. When I got up in the morning my toe was red.  Resolved by 1/13. On 1/15/21 Friday- started with back pain about noon. By 8 PM had also developed frontal headache, chills, loss of appetite, fatigue. On 1/16 developed scratchy throat and a rhapsody voice. Also small red lump at injection site had developed. Chills had resolved. Woke Saturday night with a stabbing pain in my right back between spine and shoulder blade. Did not last too long.  Back ache resolved by Monday 1/18.  Thursday last day of raspy voice.  Also appetite was back. Today, 1/22 frontal headache still on occasion but relieved with Tylenol. COVID test 1/19 negative.
No additional AE; a dose of improperly stored vaccine was administered to a patient on 21 OCT 2022; This spontaneous report was received from a vaccine coordinator and refers to a 12-month-old patient of unknown gender.  The patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant medications were not reported.  On 21-OCT-2022, the patient was vaccinated with a dose of improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #U034522, expiration date: 22-JUN-2024, administered for prophylaxis (dose, strength, site, and route of administration were not provided) (product use issue). The temperature excursion included 33.6 Fahrenheit (F) for 3 hours and 46.9F for 1 hour 48 minutes. The previous temperature excursion included 34.3F for 48 minutes, 34.3F for 1 hour 42 minutes, 34.9F for 1 hour 18 minutes and 34.3F for 1 hour 18 minutes. No additional adverse events details or product quality complaints were reported (no adverse event).
I have selected the first flu vaccine, but did not get information about the specific type other than iiv4. Felt hot at night and had a 99.4 fever, but in the middle of the night, woke feeling nauseous and had a fever of 102.4. Tylenol brought it down to 100.6, but after four hours it was back to 102.4. He has a fine appetite and mental state.
Reports headache beginning the day after the injection and continuous for six days after thus far. Headache is moderately severe.  (Headache Impact Test score is 62, which indicates very severe impact from headache.) Describes central head pain without migrainous features.
arm became red and raised where the injection was/swelled up/ about a 3-inch circle where it was raised; arm became red and raised where the injection was; Itchy, about a 3-inch circle where it was; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm became red and raised where the injection was), VACCINATION SITE PRURITUS (Itchy, about a 3-inch circle where it was) and VACCINATION SITE SWELLING (arm became red and raised where the injection was/swelled up/ about a 3-inch circle where it was raised) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.  On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 05-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm became red and raised where the injection was) and VACCINATION SITE PRURITUS (Itchy, about a 3-inch circle where it was).   On 06-Feb-2021, the patient experienced VACCINATION SITE SWELLING (arm became red and raised where the injection was/swelled up/ about a 3-inch circle where it was raised).   At the time of the report, VACCINATION SITE ERYTHEMA (arm became red and raised where the injection was), VACCINATION SITE PRURITUS (Itchy, about a 3-inch circle where it was) and VACCINATION SITE SWELLING (arm became red and raised where the injection was/swelled up/ about a 3-inch circle where it was raised) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
really not feeling well; really lethargic; and slept the whole day; 102 fever/temperatures have been 102, 101, and 100.4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Jan2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 Immunization.  The following information was reported: PYREXIA (non-serious) with onset 14Jan2023, outcome "not recovered", described as "102 fever/temperatures have been 102, 101, and 100.4"; SOMNOLENCE (non-serious) with onset 14Jan2023, outcome "unknown", described as "and slept the whole day"; LETHARGY (non-serious) with onset 14Jan2023, outcome "unknown", described as "really lethargic"; MALAISE (non-serious), outcome "unknown", described as "really not feeling well". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter was calling about the COVID-19 Vaccine Booster. Her and her husband both got the latest COVID-19 Vaccine booster on Friday. Friday was fine but then Saturday morning, her husband had a fever and slept the whole day and was really lethargic and then running 102 fever. Sunday running her husband was still running a fever and has one this morning again. The temperatures have been 102, 101, and 100.4. Her husband was really not feeling well. She needs some guidance on what to do.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulder) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included VITAMIN C [ASCORBIC ACID], TOCOPHEROL (VITAMIN E [TOCOPHEROL]), TURMERIC [CURCUMA LONGA RHIZOME], ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION), MULTI VITAMIN & MINERAL, ATORVASTATIN, LISINOPRIL and METOPROLOL for an unknown indication.    On 23-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ARTHRALGIA (Sore shoulder). At the time of the report, ARTHRALGIA (Sore shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Pt stated vomiting-4-5 hours after Roto- vomited 5x each at 5 minutes apart. Then was fine.
Myalgia, Arthralgia, Nausea Vomiting, SEVERE ABDOMINAL CRAMPING AND PAIN Narrative:
This spontaneous report as received from a consumer read on the news website. A doctor talked about his teenage daughter became severely ill after her first dose of GARDASIL (vaccination date, strength, dose, route and lot # not reported). The outcome of the adverse event was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Nausea-Medium, Systemic: Tachycardia-Medium
A booster dose of Pfizer Covid-19 vaccine  was administered to this 12 year old patient .  No known adverse events occurred at this time.  Parents were instructed to report back if any adverse  events  occur  within the next 14 days.
no adverse reactions; it started leaking out around the hub and did not come out of the needle; none of the medication went in the patient because there was still 1/2 of it in the syringe as well as what leaked out around hub.; From where did the leaking occur? Between the syringe hub/Luer lock and syringe needle? YES; This spontaneous report was received from a nurse referring to a 12-year-old male patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were unknown by reporter. On an unknown date in 2022, the nurse received 1 box containing 2 cartons of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with 5 pre-filled syringes per carton; 10 pre-filled syringes total. Nurse stated they used the first 5 pack with no problems.  On 19-DEC-2022, the patient was vaccinated with 1 dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter (ml), lot #U019413, expiration date: 01-NOV-2023, administered intramuscularly (IM) as prophylactic vaccine for Human Papillomavirus (HPV) (strength 0.5 mL).  On 19-DEC-2022, the nurse opened the second carton of 5 syringes and took one out and attached the needle to the hub/luer lock part of the syringe. It seemed to be securely attached and then she felt a click and it kept turning. As she pushed the vaccine through the syringe and tip of needle to get the air out, it started leaking out around the hub and did not come out of the needle so she disposed of it and got another pre-filled syringe from the carton. She stated this one seemed to be fine and the needle securely attached to the syringe without issues but while administering to the patient, the liquid came out all around the hub where the needle connects (syringe issue; poor quality device used; device connection issue). She said she knows none of the medication went in the patient because there was still 1/2 of it in the syringe as well as what leaked out around hub. The patient had no adverse reactions and did not need treatment (no adverse event). The outcome of all the events was unknown (also reported as recovered). The action taken with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) regarding all the events was not applicable (also reported as therapy discontinued).  The causal relationship between all the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Patient fainted while sitting in observation area. Patient regained consciousness within a few seconds. Patient was assessed and left vaccination clinic in stable condition.
If it has been 7 months since 1st dose of shingles vaccine can you get the 2nd dose?; This case was reported by a consumer via (Shingrix GSK Chatbot ) interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 7 months ago).   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 details were reported as follows: The age at vaccination was not applicable for this report. The patient received 1st dose 7 months ago and till the time of reporting patient did not receive 2nd dose which led to incomplete course of vaccination. No further information was reported. Follow up was not possible as no contact details were provided.
He said his upper arm was swollen and hurting. It was swollen all the way up to his ear. Doctor advise him to take BENADRYL. (It started swelling on the 8th).
Inadvertently gave MCV4 subcutaneously instead of intramuscularly.    Called the STATE Representative for agency and was told that the dose was still valid; no need to repeat the dose.   No adverse reactions occurred while client was in the health center
This spontaneous report was received from a doctor of pharmacy concerning an unspecified number of patients of unknown age and gender. On an unknown date, patients were vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). No concomitant medications were reported. On an unknown date, the patients experienced injection-site swelling and stinging while ZOSTAVAX. Patients sought medical attention (notified pharmacy). On an unknown date, the patients recovered quickly. The relatedness for injection-site swelling and stinging was unknown for ZOSTAVAX. Additional information is not expected.
Information has been received from a medical assistant referring to an adolescent patient of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. On 18-NOV-2015, the patient was vaccinated with second dose of improperly stored VAQTA, lot # L028666; expiry date 04-NOV-2016 (dose, route and frequency unspecified). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
axillary t102; h/a, nausea, red & swollen arm; pain in arm & shoulder;
Felt dizzy and sweaty after she had her flu vaccine. Taken to health service to rest and be observed. Drank sierra mist and ate saltine crackers. Felt better and discharged 45 minutes later. BP% 90/60
Patient called after 50 minutes of receiving the vaccine saying  that 40 minutes after he got the vaccine he felt his throat funny and red so I advised the patient to go to the ER and I called him back at 3pm and he said he is at the ER
Headaches, fatigue, muscle soreness initially then increase in blood pressure (may have been sooner after the injection than reported) blood pressure was taken at medical appointment.  required 4 different medications and a visit to the local hospital's emergency room to bring it back to a normal range.  Blood pressure was in crisis stage.  Both my wife and I had similar reactions to the inoculation. Neither one of us has had high blood pressure before the vaccination
Patient had constitutional symptoms (fatigue, body aches, poor appetite) after the first dose that resolved after few weeks. However, 7-10 days after the second dose, he developed fever, rash, severe fatigue, musculoskeletal pain, weakness. The patient's clinical status improved gradually without treatment although even 5 weeks later he continues to experience significant fatigue, musculoskeletal pain and weakness.
Monovalent mRNA vaccine administered for a bivalent mRNA dose. Patient was given the monovalent mRNA vaccine, as I was not aware at the time, that the EUA had been withdrawal by the FDA.  My supervisor received noticed on 05/01/2023 from Health Department with a link to the Agency which announced updates to Covid-19 vaccines.  That the Bivalent Moderna & Pfizer BioNTec vaccines were to be used for all doses administered to those 6 months of age and older.  In the announcement, NO where did it state that this change had gone into effect the month prior. I was forwarded the email announcement  on 05/02/2023 and it was read on 05/03/2023 as soon as I returned to the clinic office from doing vaccinations I destroyed all remaining doses of our Pfizer monovalent mRNA FP7136 vaccine.  The patient suffered NO adverse affects and had NO adverse events following his vaccination. This patient was notified on 05/24/2023 regarding the need to have his vaccine repeated with the updated Pfizer Bivalent vaccine and the patient stated that he wants to wait till early June to get his next vaccine.  Patient still remains in our custody and will be offered the Updated Pfizer Bivalent vaccine this week.
Extremely fatigued unable to perform daily activities. Worst was next day after vaccine (Thursday) through the 5th day (Monday). Starting Monday afternoon thru Wednesday afternoon (Now) extreme sweating, like the soaked clothes kind. Still extremely weak and fatigued
Fever of greater than 101 for three days. Upset stomach. Chills and headache. Muscle aches. Tenderness at injection site.
To ED 11/11 states that she was feeling weak and fatigued since yesterday evening, which was worse this morning. Has had some nasal congestion and a mild cough. 11/12 COVID Pneumonia diagnosis. 11/14  O2 supplement to maintain SPO2 > 92%,  with weaning attempts as tolerated.Lovenox 40 twice a day, 11/17 electrolytes abnormalities, The patient finished treatment of remdesivir.  She is on Decadron.  She is doing well.  She is only 2 L oxygen.  11/18 Pt discharged to another facility.
This spontaneous report was received from a healthcare worker and refers to a 3 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored PROQUAD lot # L010142, expiration date: 24-SEP-2016 (dose, therapy type, route of administration and anatomical location were not reported). There were no adverse effects reported. This is one of the several reports received from the same reporter. Additional information has been requested.
there was slight edema at the site of injection and the patient was only able to raise his arm slightly due to the pain; complaining of arm pain; the patient was vomiting; The patient was seen and there was slight edema at the site of injection and the patient was only able to raise his arm slightly due to the pain; This non-serious case was reported by a physician via call center representative and described the occurrence of injection site edema in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number 4m24z, expiry date 31-JUL-2026) for prophylaxis.   On 18-SEP-2023, the patient received Bexsero (left deltoid). In SEP-2023, an unknown time after receiving Bexsero, the patient experienced injection site edema (Verbatim: there was slight edema at the site of injection and the patient was only able to raise his arm slightly due to the pain), pain in arm (Verbatim: complaining of arm pain), vomiting (Verbatim: the patient was vomiting) and mobility decreased (Verbatim: The patient was seen and there was slight edema at the site of injection and the patient was only able to raise his arm slightly due to the pain). The patient was treated with paracetamol (Tylenol) and methyl salicylate (Icy Hot). The outcome of the injection site edema, pain in arm, vomiting and mobility decreased were unknown.   It was unknown if the reporter considered the injection site edema, pain in arm, vomiting and mobility decreased to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site edema, pain in arm, vomiting and mobility decreased to be 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: GSK Receipt Date: 20-SEP-2023 The reporter who stated that patient received Bexsero on Monday.  On Tuesday, the patient's mother called the office and stated that the patient was complaining of arm pain (left arm).  The patient was seen and there was slight edema at the site of injection and the patient was only able to raise his arm slightly due to the pain.  The patient was instructed to take Tylenol and Icy Hot.  This morning, the mother called again to state that the patient was vomiting. The reporter consented to follow up.
This information was reported to this writer. Immediately after receiving the second dose of the Pfizer vaccine, the patient reported a "weird sensation" in his chest. The patient became pale, and reported nausea and lightheadedness.  According to the vaccinator it seemed as though the patient went into a syncopal episode. A nurse attempted to do a sternal rub to wake the patient up but was unsuccessful. The patient was then laid onto the ground and woke up; attempted to sit patient up and then went into another syncopal like episode. EMTs were notified and were on their way  to attend to the patient. Patient's feet were elevated. No history of vaccine reaction. Patient had eaten and had fluids 2 hours prior to the vaccine. Patient was sat up again with assistance but immediately felt lightheaded and had another syncopal like episode. He was again placed in a supine position with feet elevated. Immediately reported improvement of symptoms. Patient had several sips of juice and was placed on  a stretcher and taken to a back room. Patient had mom and sister at his side. As the patient remained in supine position, he denied nausea and lightheadedness; no chest pain, no dizziness. Patient was alert and oriented. Remained pale in color according to his father who just arrived. Per the advice of the EMTs, patient was transferred to hospital per ambulance.
Approximately 1 week after my 2nd dose was administered I began to get small red bumps various areas of my body that are painful and itchy.  My diet, medications and activities have not changed.  My concern is will this become more prevalent or worse?  I am not experiencing anything other than extreme discomfort from the rash.
Patient complained of chest pain and was taken to ER. At the ER he complained of chest pain 6/10 and SOB. Troponin at initial hospital was 1031 and EKG showed ST depression in V1 and ST elevation in aVF and Lead II. He was transferred to hospital. Initial chest pain rated 2/10. Repeat labs showed Troponin 34000 and EKG with ST depression in V1 and ST elevation in aVF and lead II. He was admitted for COVID-19 vaccine myocarditis.  On admission cardiology was consulted and requested repeat troponin, BNP and an echocardiogram in the AM of 9/28. IV meds were started at that time as well.  EKG findings, and elevated cardiac biomarkers are more consistent with that of a myopericarditis. His echo on 9/30 is normal, with no evidence of dysfunction, pericardial effusion, or significant edema. On 09/27 Patient did complain of an aching chest pain at 5/10 rating, this was relieved with Toradol and no further dose of Toradol or pain was reported throughout stay. Naproxen 220 mg every 12 hours started on 9/28 and given as scheduled until 9/30 prior to discharge. We PO challenged Patient on 09/27 and he tolerated food and drink well, mom states he ate close to his home baseline. Troponins continued to down-trend, and repeat Echo and EKG were reassuring.  Outpatient follow up with Dr. at discharge. Will need Halter monitoring to be set up by cardiology at follow up.