chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash at local site of injection ever since he got vaccine; This spontaneous case  was retrieved on 29-Sep-2023 from a physician via Communications (reference number: SEQW23-02821) and concerned elderly (over 65 years old), male patient.  The patient's concurrent conditions included high blood pressure and heart failure. The patient's concomitant medications included allopurinol, amlodipine, atenolol, Lipitor (atorvastatin calcium), Proscar (finasteride), and omeprazole, all used for an unreported indication.  On an unspecified date in Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration and anatomical location: not reported) as every year shot, as reported. The batch number was not reported.  On an unspecified date in Oct-2022, an unknown amount of time after receiving Fluad Quadrivalent, the patient experienced rash at a local site of injection ever since he got vaccine. The patient was treated with topical steroids like betamethasone.   The outcome of the event was not reported.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: The event of vaccination site rash is assessed as possibly related to Fluad Quadrivalent due to anatomical plausibility; Sender's Comments: The event of vaccination site rash is assessed as possibly related to Fluad Quadrivalent due to anatomical plausibility
STROKE; Facial droop; This is a spontaneous report from a contactable physician.  An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscular on 02Mar2021 (Batch/Lot Number: EM9809) as 2ND DOSE, SINGLE for covid-19 immunisation; and carbidopa, levodopa (DUOPA), via percutaneous j-tube from 2018 (Batch/Lot number was not reported) and ongoing, at unspecified dose for advanced parkinson's disease.  Medical history included maternal history of strokes, and paternal history of strokes, both on unspecified dates. Concomitant medication included carbidopa, levodopa taken for an unspecified indication, start and stop date were not reported. Historical vaccination included first dose of BNT162B2 on 20Jan2021, intramuscular, with lot number: EL19261 for covid-19 immunization.  The patient experienced stroke on Apr2021 with outcome of unknown, and facial droop on Apr2021 with outcome of recovering. Details were reported as follows: The patient felt like she experienced a mini stroke in Apr 2021. She had her Peg and J tube replaced on 16Apr2021 because they came completely out. Her husband was not sure if the pump was working states he could not saw the medication. Her husband had the pump disconnected from her. NCM advised her husband to run the pump over paper towels. Her husband did as instructed and could then saw the medication. He then connected patient to the pump and the pump ran without any error codes or alarms. Her husband wanted to make sure patient did not need a new pump since she got new tubing. NCM assured that the current pump seemed to be working fine with the new tubing. She left sided mouth droop in Apr 2021. She was taken to the local hospital via emergency medical services (EMS). She was then transferred to Hospital in for evaluation. She was in the ER awaiting a bed for 20 hours. The primary reporter did not know if any tests or medicine obtained as he did not receive any paperwork. After 20 hours, she was discharged from the ER home. She had a brain waves test a few days later to confirm if stroke had occurred. The primary reporter stated he did not feel the COVID vaccine was related to he events of Mouth droop and possible stroke. The patient underwent lab tests and procedures which included brain waves test: results pending on 21Apr2021.  The action taken in response to the event(s) for bnt162b2 was not applicable, and for carbidopa, levodopa was dose not changed.; Sender's Comments: Based on information provided, considering the age and medical history of the patient, the event stroke is assessed as unrelated to BNT162B2. The event "facial drop" is assessed as symptom of the event stroke, hence not related to BNT162B2 either. 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.
This spontaneous report was received from a licensed practical nurse regarding a 17 years old female patient. On 28-OCT-2009, the patient was vaccinated with dose 1 GARDASIL (lot #, expiry, route and dose not reported). No concomitant medications were reported. On 17-SEP-2012, the patient received her second dose of GARDASIL (lot#, expiry, route and dose not reported). No adverse effect has been observed or reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Myalgia; Fatigue; Chills; The reporter did not know if this is due to another infection or a viral infection; The reporter did not know if this is due to another infection or a viral infection; This is a spontaneous report from a contactable physician (patient's husband). A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right deltoid on 08Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation.  Medical history and concomitant medications reported as none. The patient also received first dose of BNT162B2 via intramuscular injection in right deltoid on 11Mar2021 (unknown lot number and expiration) for COVID-19 immunization.  The patient experienced myalgia, fatigue and chills on 20Apr2021. The reporter asked if there have been any reports of delayed adverse events after receiving the second dose of the COVID vaccine. Clarified that by delayed adverse events he meant 12 days after receiving the second dose of the COVID vaccine, versus a few days after. The patient had a negative PCR COVID test on 22Apr2021. The reporter did not know if patient's myalgia, fatigue and chills is related to the COVID vaccine. That is why reporter called to find out if there have been any reports or delayed adverse reactions. The reporter did not know if this is due to another infection or a viral infection. The patient recovered from the events on 23Apr2021. The events were assessed as serious (medically significant).   Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events myalgia, fatigue and chills cannot be excluded. The events infection and viral infection are most likely intercurrent medical conditions and are assessed as unrelated to the suspect drug. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.
Cytokine Release Syndrome, agonizing full body inflammation, headache, low grade fever, drenching night sweats, extreme muscle weakness, and fatigue. Admitted to hospital March 26 for extensive testing and discharged April 2 with no diagnosis. Given Prednisone 60mg, Ibuprofen 400mg every 6hr., Carvedilol 10mg ER, Gabapentin 600mg.  All symptoms persist, but currently controlled with the medications with occasional flare ups.
This spontaneous report was received from a medical assistant concerning an approximately 13 year old ("reported as over a year ago, an unspecified 12 year old patient") of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. In approximately January 2017 (reported as "over a year ago"), the patient was vaccinated with GARDASIL (strength, dose, route, lot number and expiration date were not reported)  for prophylaxis. On 10-JAN-2017, the patient returned to the physician's office to received the second dose of GARDASIL 9 lot number N012093, expiration date: 13-JAN-2020 (strength, dose and route were not reported). No adverse effect reported.
Pt received pfizer bivalent 5-11 year old formulation after the BUD of 12/28/2022.  No adverse event reported by patient's mother.
Late menses, insomnia, UTI, chronic fatigue, body chills, muscle weakness, chest pain, extreme fatigue and nerve pain.
Numbness in (L) arm, pain in (L) scapula that radiated to (L) chest under her (L) clavicle. Increased pain trying to lift her (L) arm. Numbness in (L) palm.
Nine patients received vaccine from punctured vial stored more than 12hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nine patients received vaccine from punctured vial stored more than 12hours) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nine patients received vaccine from punctured vial stored more than 12hours). On 22-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Nine patients received vaccine from punctured vial stored more than 12hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment was reported. pharmacist said the incidence happened 28days ago   This case was linked to US-MODERNATX, INC.-MOD-2021-154535 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-154535:Crosslink
Our baby received all his standard 2-month-old shots.  He was fine for the first few hours after the vaccines, but then around 4 or 5 hours after he received his shots, he started crying hard and seemed in pain.  He cried for 4.5 hours, which was very unusual for him.  We gave him infant Tylenol after he started crying, and then a second dose again 4 hours later.  It was after the second dose, and it being late at night, that he was finally able to fall asleep.  He woke up fine the next day though and seemed back to his normal self.
Hives, raised welts, skin remains raised when I scratch it (dermtographia or something like that). Began 14 days after booster shot, has slowly decreased over the last 6 weeks, reflared up again today, 6.5 weeks after first symptom
Patient went to bed and woke up with severe swelling in the face. Patient went to urgent care and received steroid treatment - swelling continues 2 days later on 10/13/16.
This case was reported by a consumer and described the occurrence of whooping cough in a 27-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included eczema. There were no concurrent medications. On 5 May 2012 the subject received unspecified dose of BOOSTRIX (unknown, right arm). On 23 July 2012, 79 days after vaccination with BOOSTRIX, the subject experienced whooping cough and vaccination failure. This case was assessed as medically serious by GSK. The subject stated that she began to experience symptoms on 23 July 2012 and that whooping cough was confirmed by nasal swab on 06 August 2012. She stated that her healthcare provider prescribed her antibiotics. At the time of reporting the whooping cough was unresolved. Follow-up information as received on 05 November 2012 via physician who reported "the patient has not received any vaccination in our office. She either received the vaccine in the hospital or from another physician. Please contact the patient." No other information was provided.
I felt fine initially and  felt good enough to leave 10 min after the shot.  I decided to get some food to make sure I wasn't hungry on the hour and thirty min drive home.  Unfortunately about 40minutes after receiving the second vaccination I started to get severe nausea, my tongue started to tingle and I felt a strange metallic taste in my mouth.  I then started to get a severe headache and began vomiting profusely while driving home.  My eye became extremely light sensitive and I was not even able to keep water down.  I became so extremely tire that I had to pull over.  I then called my husband to help talk to me over the speaker phone so that I could get out home as soon as possible.  It was awful.  I was vomiting while talking to him, and had to pull over again.  I was so tired and in pain the entire drive home.  When I got home I was so tired I just fell asleep on the couch and couldn't stay awake or eat/drink anything.  I started to feel better around 7pm, and then I felt fine.  Today I'm just a little tired and my arm hurts and has a bump, but other than that I feel fine.
After taking my first Pfizer vaccine I started to have altered taste and smell. I originally had covid 19 in December and did lose my taste and smell but it had come back 100% after 2 weeks. I had my taste and smell back and then went to go get vaccinated on 2/17/21. Friday 2/26/21 when I had ate my lunch the chicken tasted old and like it had gone bad. I thought that I had just had bad food. Turns out that was the first time that my taste seemed off. The next time I ate chicken a couple days later it tasted rancid and I had to spit it out. This started with chicken and then progressed to beef, pork, any meat. A week later it progressed to where garlic started to taste bad. Meat and Garlic have the same rancid smell to them. It then progressed to my bowel movements smelling the same way. Then progressed to always having the bad taste in the back of my mouth. About 2-3 weeks ago tap water started to smell very strongly of chemicals.  Now it has progressed to Meat, Garlic, onions, or anything in garlic family, strawberries, zucchini, peanut butter, chemical smell of water, coffee, and then just foods here and there that do not taste terrible but do not taste good either. The only foods that taste completely normal are sweets like icecream or cake. My diet is now consisting of protein bars, protein shakes, salads, chips, cheese, and sweets. It?s been challenging especially since garlic is put in 90% of all food products it feels like. If I open the container of garlic powder it can make me gag until I vomit if I smell it long enough. I did mention this to my Primary Care Doctor. She stated that she would be willing to refer me to a specialist if my symptoms persist into June or so. Right now not only are my symptoms persisting but worsening every week. I?m concerned that I will eventually run out of foods I can eat. These symptoms are still ongoing.  It is depressing to deal with and challenging.
Elevated BP, shortness of breath, tightness of the chest/chest pain, palpations, dizziness 11 days after the vaccine.  Continued daily for four consecutive days onset.
It started with a headache approximately 8 hours after the shot. Then quickly was followed with a fever and chills. This continued until approximately 24 hours after the shot. When it turned back into just a headache. Which is ongoing. (32 hours after shot)
Sore Arm, Chills, Fever, Hot Flashes, Lethargy, Sensitive skin, headace
Got chills on the evening of my vaccination, woke up during the night with a very painful headache, dry mouth, achy, weak. Drank water. Same symptoms when I got up in the morning except feeling even worse. Drank a bunch of water, took 3 aspirins, regular strength, headache began to fade approx. 7:30 AM, strength mostly back to normal by 9 AM.
This spontaneous report as received from a registered nurse refers to a 60 year old female patient with medical history of allergic rhinitis, asthma, type 2 diabetes, GERD, HTN, insomnia and overweight and with drug reactions/allergies to DEMEROL (unknown reaction). ON 12-JUL-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J001692, Exp date as 08-MAY-2014, 0.65 ml, subcutaneous. On 29-JUL-2013, the patient developed Bell's Palsy after being administered ZOSTAVAX. It was reported that the patient began to experience symptoms on 29-JUL-2013 which included difficulty in closing her left eye, excessive blinking of her right eye and drooping on the left side of her face. This patient called the physician's office on an unspecified d ate, but the patient was seen in the office for evaluation on 31-JUL-2013. The unspecified physician prescribed an unspecified dose of prednisone (manufacturer unknown) and valacyclovir, along with over the counter artificial tears to manage the patient's symptoms. The nurse reported that the  patient was instructed to follow up with the physician in 10 days for re-evaluation. The outcome of bell's palsy was reported as recovering/resolving. Additional information has been requested.
8 x 8 reaction. Left thigh 5 cm bigger than right thigh. Red, swollen knot.
Pt. recently moved here from another country.  C/O fever 102-104, with vomiting.  No rash reported.
(R) arm red swollen X 2 days; tender - Fever increase 101.0. - Will treat  KEFLEX 500mg #30 T po tid for 10 days.
Patient returned today, 9/12/14 for recheck of arm after vaccines given 9/10/14. On 9/11, (R) upper arm became red, swollen, warm, and very tender. Low grade fever and diarrhea. Mild improvement today. On exam, low grade temp. RUE from mid to shoulder very erythematous, tender, skin tight with 2 small blisters. Area marked, tx with cephalexin 500mg BID, BENADRYL PRN, MOTRIN PRN.
mild headache; tiredness; bruised arm not at injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 64 -year-old female (not pregnant at time of vaccination) patient received her  first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Ek9231), via an unspecified route of administration (on the left arm) on 07Jan2021 14:30 (at the age of 64-years-old), single dose for COVID-19 immunization. Relevant medical history included Allergies, mvp, hbp, thalassemia all from an unknown date. The patient's concomitant medication was not reported. The patient experienced mild headache, tiredness and bruised arm not at injection site, all from an unknown date. The patient underwent lab tests and procedures which included sars-cov-2 test on 10Jan2020, 15May2020 and 01Oct2020, all negative. Patient has no other vaccine in four weeks.  No covid prior to vaccination. No treatment received for the adverse events. The outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021143321 same reporter/patient/drug, different events separated with time
she received two doses of GARDASIL 9, but never received her third dose; no additional AE reported; This spontaneous report was received from a consumer, a female patient of unknown age reporting on herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date (reported as approximately three years ago), the patient was vaccinated with two doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot #, expiration date were not reported) for prophylaxis, but she never revived the third dose (Inappropriate schedule of vaccine administered). The patient was inquiring on the dosing schedule of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). She preferred to contact her physician regarding this information and disconnected the call before additional information could be collected regarding this adverse event. No aditional adverse event was reported.
Induration, erythema, tenderness, edema, warmth, first noted one day after vaccine was given. Mother tried cold compresses and TYLENOL, with no relief. 9/17 48 h after shots 16 cm x 11 cm erythema/induration.
can't see well the next day; This spontaneous case was reported by an other and describes the occurrence of VISUAL IMPAIRMENT (can't see well the next day) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced VISUAL IMPAIRMENT (can't see well the next day). At the time of the report, VISUAL IMPAIRMENT (can't see well the next day) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-May-2021 contains no new information.
ACUTE STROKE DUE TO ISCHEMIA, UNSPECIFIED TYPE AND ARTERY  5/5/2022 --  RECURRENCE OF SAME SYMPTOMS
approx 24 hrs p/vax pt had 1/2" circumference area @ site, reddened, swollen & warm to touch; also pruritic; pt devel blister like welts; area still apparent & darkening in color;
Per Mother: Dizziness, Behavioral Changes (Giggling, Laughing), inability to comprehend basic math function.
swollen ankles; headache; This is a spontaneous report from a contactable consumer or other non healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced swollen ankles and headache on an unspecified date with outcome of unknown. Follow-up attempts are completed. No further information is expected.
Resident received the bivalent booster 10 days prior to the recommended time. His last booster had been administered on 8/17/2022
All vaccines by Pfizer: After 2nd vaccine on 4/16/21, approximately 2nd week of June, I started noticing under my eyes very puffy, I also began having hot flashes, racing heart, insomnia and dropped wt from 123 to 114 in a short time. I was traveling at the time and when returned home in August I set up an eye doctor appointment. This appoint was canceled by the office twice. On Oct. 25th, I was referred by my eye doctor to see a Graves eye disease, also I had blood work done that confirmed I had Graves Disease plus T.E.D. Thyroid Eye Disease.
103+ fever, severe diarrhea (every hour), nausea, fatigue, head and body aches for about 48 hours
15 days post vaccine #2, patient complained of bilateral hand swelling and stiffness. Also had shoulder pain bilaterally. Swelling persists in hands, wrists and distal forearms. Bilateral upper extremities achy with pain (with lifting) and pain upper back. No headache or double vision. She did not improve with prednisone 15mg nor Nabumetone. Rheumatology working up now. She resumed pravastatin at 2 days per week on 2/14/2021.