chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid; Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An elderly male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid".  Clinical course: It was reported that patient get Covid but very mild.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from registered nurse refers to a unspecified patients of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL (strength, dose unit, route, lot # and expiry date unknown). Other suspect therapies included VAQTA and LIQUID PEDVAXHIB, (strength, dose unit, route, lot # and expiry date unknown). On an unknown date with GARDASIL, VAQTA and LIQUID PEDVAXHIB were improperly stored. Registered nurse reported that she was unsure if improperly stored vaccines were administered and no adverse effects reported, but she does not think so. Registered nurse also reported that another nurse at VFC handles the issue. The outcome of unsure if improperly stored vaccines; GARDASIL, VAQTA, PEDVAXHIB, were administered and no adverse effects reported was unknown. Additional information has been requested.
This spontaneous report as received from a nurse via a company representative refers to two patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with 1 shot of PNEUMOVAX 23 (dose, lot# and expiration date were not reported) subcutaneously. Concomitant drug was not reported. On unknown dates the patients both experienced shooting pain that went down from the injections sites to their finger tips after the vaccination and sought unspecified medical attention. The patients' condition improved and PNEUMOVAX 23 was not reintroduced. The causality was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
On 8th day after vaccine left arm at injection site itchy, hot, red.  Moderna arm.
Approx. 1 hr after injection, pt. developed nausea, headache, fever/ sweating, muscle aches. This lasted all day Tuesday 2/26/2019, and started subsiding Wednesday morning 2/27/2019.
A nurse reported that a female, now 48 years of age, received an injection of Tetanus and Diphtheria Toxoids Adsorbed, 20 years ago and subsequently developed flu-like symptoms. She also developed a 6 inch wheal at the injection site. She recovered.
55 patients received a dose of a vial after 12 hours of initial puncture/vials were being used past the recommended 12 hour post puncture time; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture/vials were being used past the recommended 12 hour post puncture time) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture/vials were being used past the recommended 12 hour post puncture time). On 16-Aug-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture/vials were being used past the recommended 12 hour post puncture time) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was given.  No treatment medication was given. Reportedly, there were two vials that were punctured and used some time between June and November 5. Vial punctured on 01-Jun-2021 and stored in refrigerator once punctured.   This case was linked to MOD-2021-418964 (Patient Link).
Nausea, Fever, Body aches, Night Sweats, low energy, very sore arm
This spontaneous report as received from a registered nurse refers to two unspecified patients of unknown age and gender. The nurse reported that since 17-OCT-2014, the patients were vaccinated with a dose of VARIVAX (Merck) (dose, route and lot # not reported) that was improperly stored. This was supported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Migraines, chills, fever, body aches, rash/blisters appeared on stomach, chest and back.
Received Tdap, MENACTRA and Hep A on 7-30-14. Per pt, broke out in itchy rash along bra line/chest. Petechiae observed in that area. Hydroxyzine was rx'd.
1-21-10 - vomited, then okay rest of day. 1-22-10 - red cheek, swollen bumps, diarrhea (AM) fever 101. 1-22-10 - (PM) got bumps on leg; at injection site. 1-23-10 - to doctors office visit with rash and bumps over limbs, wasn't drinking fever, vomiting admitted to hospital.
Client received vaccines and relaxed she felt okay - no complaints. Client left clinic and parent reports outside of clinic client fell onto lawn. Client reports had headache and blurry vision before she fainted and fainted and fell onto lawn. Noted: Nose bleed, abrasion beneath (L) Nostril, inner low lip, redness and swelling of (L) upper cheek area. Provided first aid, BP114/72 P-76 R-20. Provided crackers and water. Seen by Doctor here
numbness in LUE 5 minutes after vaccine. Nausea and lightheadedness the next day Narrative:
erythema to upper arm from shoulder to elbow, warm to touch, nontender, afebrile.
First was a generalized local warm, swelling and discomfort at site and it progressed by a fever starting quickly to 104 degrees.  Fever lasted about 40 hours.  The pain and swelling went up to the lymph and affected both cervical nodes.  Having some mild difficulty swallowing and redness in throat.  Both ears were swollen, red and hot to touch. Had 7/10 headache for 24 hours.  Pt went to primary MD for eval and treatment on 11/22.  He prescribed Prednisone 40mg bid x 2 days the 20mg x 2 days. Today (11/24 pt improved but still some redness and swelling in face (sinus) continues.
I had nose bleeds within 12 hours of vaccine and it was just gushing blood, and the next day it stopped and I had the worst headache ever and I was tired and my menstrual cycle was thrown off for a couple of months after the vaccine. I noticed 2 weeks after vaccine my cycle wasn't normal and it was irregular. It's mostly back to normal now at this point. COVID Symptoms started on  09/23/2021 and I thought I had a sinus infection. I experienced sinus pressure, headache, burning nose, congested, fatigue, and loss of sense and smell. I tested on 09/29/2021 and it was positive. Symptoms lasted from September 23-October 5th or 6th. I am still experiencing fatigue and headaches but I'm able to go back to work. I've never had any lung issues though. I was nauseous and threw up but it may have been from the alka seltzer. My face burns, my nose and my face was on fire and that lasted for the longest, about 7 days after Covid.
It started swelling, hurting, and itching, eventually expanding to an area about 4 inches square; it was raised, red, warm to the touch, and painful when touched. Now, two days later, the symptoms are receding, but it still itches.
Information was received from a registered nurse concerning a healthy 52 year old female with allergy to ACCUPRIL who on 04-APR-2005 was vaccinated with PNEUMOVAX (lot # 649913/0577P).  The nurse reported that the patient developed erythema and hardness of the injection arm within 24 hours.  The nurse also reported that the patient experienced pain and itching on the whole arm of injection.  The patient was treated with warm compresses and BENADRYL at bedtime.  The patient sought unspecified medical attention.  Subsequently, the patient recovered from erythema, hardness of the injection arm, pain and itching. Additional information has been requested.
I received my first vaccination on March 24, 2021 at 9:50 am at Hospital. Within 24 hours I started to get migraine headaches. I never have gotten migraine headaches. The migraine headaches never went away. After several weeks I contacted my doctor. He prescribed migraine medications. The first two medications didn?t work, the third helped. I had taken them for about two weeks and thought I would try to go off of the medicine, no luck, the migraine continues to exist. It?s been over two months. I finally had a MRI which came back negative. I really need some answers to try to figure this out. I had never had migraines in my life and now I have a constant migraine all the time. Looking for solutions not medications. Thank you.
Telephone report received from a physician on 12/11/00, regarding an adverse event related to administration of Fluvirin. An MD reported that he vaccinated his 31 year old son and approx. 8 days later, the son experienced an "aura" followed by a motor vehicle accident. The pt experienced a grand mal seizure which was witnessed by the paramedics at the scene of the accident and a subsequent grand mal seizure in the ER where he was treated and released. Further information has been requested.
Patient started having trouble breathing and felt like she was going to vomit. This happened about 3 minutes after the injection was given in the left arm. We took her blood pressure and it was 135/95, pulse was 74 and patient was fully coherent. We called 911 and EMT arrived in 5 minutes.
Patient felt numb on hands, sweating, and fainting after receiving the covid vaccine from the pharmacy.Patient was full alert and responded to all the requests. We did call and EMS arrived. They did check patient health and everything was normal . Patient did not want to go to the hospital and felt better after drinking a bottle of orange juice. EMS crew left the pharmacy after 10 minutes. Patient sit down on a chair and drank another bottle of water. He felt very well and wanted to left the pharmacy.
doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was placed in the refrigerator was 05-Nov-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
I received the SHINGRIX 50 mcg vaccine on 1/08/2019. Initially experienced a sore arm at the injection site, which I understand is somewhat common. However, after 3 days, I experienced the onset of sciatica on the same side as the injection. This included moderate pain in the left, lower back and radiating pain to the knee area. It continues to date, and will require medical intervention if it doesn't ease up. I never had this issue before and I believe may be related to the vaccine.
p/vax pt devel chickenpox rash that consisted of less than twenty pox;
I was 5 weeks 1 day pregnant at the time of vaccination. On Tuesday, I got flu and third covid vax at the same time. Thursday afternoon I started getting an itchy red rash bilaterally on my neck/shoulder. By evening it had spread down my chest to my stomach. It felt itchy/hot. I took half a unison pill, slept 11 hours and woke to see it about 80% improved. I still feel flushed but not as itchy. I don?t know if it is related to vaccination but can?t think of another likely cause.
Broke out w/chicken pox lesion 06/01/06 headache and fever. Mom states 7 out of 36 children in her class had chicken pox recently.
Myalgia, Arthralgia, Fever, SkinRash, chills fatigue Narrative:
dizziness/lightheadedness; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration on 26May2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient experienced dizziness/light headedness on 06Jun2021 (11 days after). Asking if this is a normal reaction from the vaccine second dose is scheduled on 16Jun2021. Caller asked is it ok if I take the second dose in Jul2021. I'm not sure when the primary care doctor is available. Is there a time limit. Since I am experiencing dizziness/light headedness do you think I should get the second dose. The outcome of event was not recovered.   Information about the Lot/batch number has been requested.
Information has been received from a medical assistant and a nurse concerning a 70 year old female who on 18-AUG-2008 was vaccinated with VARIVAX vaccine (Merck) instead of ZOSTAVAX vaccine (Merck) by accident. The wrong vial was grabbed. It was human error but not a case of product confusion. The patient didn't experience any known symptoms. It was unspecified if the patient sought medical attention. No further information is available.
Came down with Covid on 12/27/2022 and again on 01/04/2023.  Tested negative in between and had no symptoms in between. Covid sysmptoms of headache, congestion, tiredness.  Same symptons both times.
I am still having difficulty using my left arm.  The muscle is very sore whenever I lift my arm for any reason.  I have showered with hot water and taken ADVIL but it seems to be only a temporary fix.  I have had the flu shot before but never this reaction.  I also have difficulty sleeping at night on that side.  I have not seen a doctor for this yet.  I keep hoping that the discomfort is only temporary and will go away.  Please let me know if you hear anyhing from the nurse again.
Fever/chills ~9 hours after injection; this continued through following day.  Severe headache for two days post-injection.
Raised red area at vaccination site (Rt deltoid) 3" x 5". Itchy and warm.
RED WELTS AREA UNDER THE ARM OF THE INJECTION SITE, NOT AT THE INJECTION SITE.
1302 patient reported to RN that she was experiencing some numbness in her lower lip and the top of her tongue. She stated it feels fat, like when your dentists numb your mouth. Patient states that this occurred when she got her 2nd Pfizer vaccine. States it lasted for about a day. She did not report to her doctor. States that she has a seizure disorder but does not take medication for it (meds were worse than the seizures) last one occurred about 2 weeks ago. States she lost her taste and smell when she had covid about 6 months ago and they never came back. bp 122/74, hr 66, rr 16, spo2 100%. Advised to f/u with her doctor, but if s/s get worse call 991. verbalized understanding. Left @ 1323
This spontaneous report has been received from a pharmacist, concerning a 66 year old obese, and retired female patient with current conditions of hypertension, hyperlipidaemia, Crohn's disease and obesity. On 04-JAN-2013 at 11:00, the patient received the first dose of ZOSTAVAX (lot number H020000) (dose not reported, subcutaneous route). No concomitant medications were reported. The patient did not have any illness at time of vaccination. On 08-JAN-2013 at 10:00 a.m., a few days after receiving the vaccine, the patient developed mild shingles outbreak across upper lip. The patient required emergency room/doctor visit and received a prescription of ZOVIRAX from primary doctor. At the time of the report the patient's outcome was recovered. This case is linked to MARRS 1212USA011063. Additional information is not expected.
Red rash that resembled chicken pox with a low grade fever.  Given Benadryl for itching, Tylenol/Motrin for fever, and used Hydrocortisone Cream for itching.  All with relief of symptoms.
Redness, swelling, pain, itching at site date after injection, slowly subsided.
Patient with 2 Pfizer COVID vaccinations, last dose 05/06/21 who admitted to hospital with incidental COVID positive test discovered.  Provider discharge note below:  "63 year old male with a history of EtOH cirrhosis complicated by ascites, esophageal varices, and hepatic encephalopathy who presented to Hospital on 2/7/22 with worsening dizziness and lightheadedness in the setting of multiple melenic stools. He had a known history of esophageal varices that had required banding. On this occasion, he denied any recent alcohol usage, NSAID usage, Pepto Bismol, or iron supplementation.    Initial evaluation in the ED revealed a hemoglobin of 3.7. He was quickly fluid resuscitated with, in total, 3u pRBC. He was started on Protonix, Octreotide gtt, and Rocephin for SBP prophylaxis. GI was consulted and EGD was performed on 2/9/22, which revealed grade III varices in the lower third of the esophageus. Large in size, two bands were successfully placed. Following the procedure, his diet was slowly advanced. He was eventually stable for discharge. It was recommended that patient have another EGD in 3 weeks for further monitoring of esophageal varices. He was furthermore sent home with the addition of Propranolol for secondary prophylaxis for the varices. Follow-up with GI and PCP scheduled."
passed out; she fell down; bruised her lower back; her back is killing her; she felt cold inside; really hot while in bed; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (passed out) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 006A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 26-Mar-2021, the patient experienced SYNCOPE (passed out) (seriousness criterion medically significant), FALL (she fell down), CONTUSION (bruised her lower back), BACK PAIN (her back is killing her), FEELING COLD (she felt cold inside) and FEELING HOT (really hot while in bed). On 26-Mar-2021, SYNCOPE (passed out), FALL (she fell down), FEELING COLD (she felt cold inside) and FEELING HOT (really hot while in bed) had resolved. At the time of the report, CONTUSION (bruised her lower back) and BACK PAIN (her back is killing her) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive.   Concomitant medications taken by the patient were not provided. Treatment activities was done with paracetamol, ibuprofen, a shot and pill.   This case was linked to MOD21-064155 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Pts mother called to report pt developed patchy and bumpy rash on chest back and arms on 09/24/2005. Slightly itchy. No fever or difficulty swallowing or breathing. Rash is stable.
Site: Pain at Injection Site-Medium, Additional Details: Patient said she is experiencing pain in both arms (it has been 3 days since injection)
Around injection site, red, swollen area on (R) arm; diameter 7 inches long, 10 1/4 inches, warm to touch.
Hot to the touch; Very swollen; Hard; Patient got the booster dose (0.5ml); Moderna administered was subcutaneous and not intramuscular; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE WARMTH, VACCINATION SITE SWELLING, VACCINATION SITE INDURATION, ACCIDENTAL OVERDOSE, and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (subcutaneous and not intramuscular) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to .5 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE and INCORRECT ROUTE OF PRODUCT ADMINISTRATION. On an unknown date, the patient experienced VACCINATION SITE WARMTH, VACCINATION SITE SWELLING, and VACCINATION SITE INDURATION. On 29-Oct-2021, ACCIDENTAL OVERDOSE and INCORRECT ROUTE OF PRODUCT ADMINISTRATION had resolved. At the time of the report, VACCINATION SITE WARMTH, VACCINATION SITE SWELLING, and VACCINATION SITE INDURATION outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   The nurse believed that the administration was subcutaneous and not intramuscular because her arm was very swollen, hard, and hot to the touch. Also, the patient received the booster dose on her right arm (not sure if it is the dominant one), same arm of the symptoms, on the back side of the arm and the lower arm.  The 1st and 2nd dose of the Moderna COVID-19 vaccine but, the caller does not know the exact dates nor the lot numbers (The caller thinks the 1st dose was on January or February).   No concomitant medications were reported. No treatment medications were provided.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patient had completed the 3-dose GARDASIL series (unknown strength, route and dose) and on an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (unknown route, strength and lot #). On 05-OCT-2015, the patient received another dose of GARDASIL (lot # J013328 and expiry date of 12-FEB-2016). No adverse effects were reported. There was no product quality complaint involved. This is one of the two reports received from the same reporter. Additional information has been requested.
Initial and follow-up information has been received from a health professional concerning a 71 year old female with hypertension, ulcerative colitis, and increased triglycerides.  At the time of being vaccinated, the patient had sinusitis and allergic rhinitis.  On 23-MAY-2007, the patient was vaccinated with a first dose of PNEUMOVAX (lot # 655152/0889F) subcutaneously.  On 25-MAY-2007, the patient developed redness at the injection site, fever, and a rash at the injection site.  The patient sought medical attention.  The patient was treated with heat and nonsteroidal anti-inflammatory drug NSAIDS.  The outcome of the events was unknown.  No additional information is expected.