chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been requested from a registered nurse concerning a 74 year old female with allergies to ofloxacin (FLOXIN) and prochlorperazine maleate (COMPAZINE) and a history of shingles (January 2007 prior to vaccination) and PPD skin test positive who on 08-MAR-2007 was vaccinated with Zostavax (Lot number 656609/0015U). Concomitant therapy included atorvastatin calcium (LIPITOR), indomethacin (MSD), baby aspirin and calcium (unspecified). In March 2007, the patient experienced burning sensation and tingling to a scarred area on her forehead above her right eyebrow. The scar was from a previous shingles outbreak in January 2007. On 19-MAR-2007, the patient was seen by a physician. The patient area on the patient's forehead was pink. On 29-MAR-2007, the patient was seen again for continued complaints of the tingling and burning sensation to the same area of the forehead. There was no breakout of rash or lesions. On 18-APR-2007, the patient was seen at the doctor's office for a tetanus injection. The nurse reported that the patient did not complain of any additional problems, and that the skin on the forehead was flesh tone. Subsequently, the patient recovered from burning sensation and tingling to a scarred area on her forehead above her right eyebrow and pink forehead. Additional information has been requested. 09/24/07 This is in follow-up to report(s) previously submitted on 5/14/2007. Additional information received on 26-APR-2007 indicated that no further information was available. Additional information is not expected.
This case was reported by a healthcare professional and described the occurrence of inappropriate at at vaccine administration in a 3-year-old subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of KINRIX (.5 ml, unknown route, batch number and injection site) which led to a inappropriate age at vaccine administration. It should be given from 4 years old.
blindness from floaters; I have blind spot in my right eye after second Moderna vaccine; blindness from floaters; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (blindness from floaters) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLINDNESS (blindness from floaters) (seriousness criterion medically significant), VISUAL FIELD DEFECT (I have blind spot in my right eye after second Moderna vaccine) and VITREOUS FLOATERS (blindness from floaters). At the time of the report, BLINDNESS (blindness from floaters), VISUAL FIELD DEFECT (I have blind spot in my right eye after second Moderna vaccine) and VITREOUS FLOATERS (blindness from floaters) outcome was unknown.            Concomitant product use was not provided.  Treatment information was not reported.  Very limited information has been provided at this time. Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information has been provided at this time. Further information has been requested.
Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: Patient received 2nd injection Pfizer, complained of mild itching. Waited 15 min then additional 10 min; pt. still had itch; benadryl 25 mg provided but no rash; itching localized at injection site/did not spread. counseled to call or go to urgent care. Pt confirmed he did not get worse, did not want to wait another 10 min.
10/1/18: approx. 12 hours after injection, patient started itching and had small random red bumps to bilat arms, bilat hip area, stomach and upper back/shoulder/neck area. 10/5/18: employee reported that the itching had not resolved on its own. No treatment taken until today. Employee checked in with me the employee Health/Infection Prevention Nurse. I took employee to the pharmacy where she was given Ceftirizine Hydrochloride 10mg PO x 1. Employee asked to monitor symptoms over the weekend and to seek further treatment if they worsen.
After the first injection, I became extremely fatigued. I did not think anything about it because I was starting a new job working early mornings, and I just attributed the fatigue to my new work schedule. I had the second vaccine a month later and the fatigue got worse, I had extreme sensitivity to light and sound. I felt like I was being stabbed in the eyes with a knife. I started after muscle spasms, pain when I would sit, sore throat that would not go away, my lymph nodes in my arm pits and throat became swollen. I had joint pain, difficulty walking. I started having severe headaches and migraines that would not go away. The fatigue became debilitating, I had shortness of breath and episodes of tachycardia. Prior to this vaccine, I rarely went to my doctor. After the second vaccine I was seeing him like once a month. I had a ton of lab work, I had CT scans, x-rays. The only thing the labs showed was a positive ANA and I had Vitamin D deficiency.  Over the next several years, I continued to see my doctor and have testing done. I was eventually diagnosed with ME/CFS (myalgic encephalomyelitis) almost 3 years after the vaccine. There are no specialists in my area for that disease, after my doctor and I both did some research, I stumbled across several research studies about ME/CFS and the Hep B vaccine. We went back though my records and the timeline linked to the time my symptoms began and the dates of the vaccines I received.
Felt intense itching on face; Developed alopecia barbae approximately 1 week from second dose/subsequent hair loss has remained permanent since; This is a spontaneous report from a contactable physician. A 33-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142), via an unspecified route of administration on 09Jan2021 14:00 at a single dose on left arm for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: K5730), on 19Dec2021 at 02:00 PM, on right arm, for COVID-19 immunization. The patient experienced developed alopecia barbae in Jan2021 approximately 1 week from second dose. After the shot (24h) the patient felt intense itching on face on 10Jan2021; subsequent hair loss has remained permanent since. The event alopecia barbae was reported to have resulted in doctor or other healthcare professional office/clinic visit, disability or permanent damage. No treatment was given for the events. The outcome of the events was not recovered. The patient did not have COVID prior vaccination and was not COVID tested post vaccination.; Sender's Comments: The causal relationship between BNT162B2 and the reported events cannot be excluded as 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 RAs, Ethics Committees, and Investigators, as appropriate.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      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 informations were reported.  No Treatment informations were reported.
Patient developed a mild fever (~100.5) a few hours after vaccination along with body aches and fatigue.  Fever lasted 4 days after vaccination and fatigue continued ~2 weeks.  Approximately 2.5 weeks after vaccination, patient complained of chest pain and shortness of breath with exertion.  She saw her physician on 3/18 and he ordered blood tests and chest x-ray.  Per physician, lungs sounded clear on auscultation.  Physician called patient on 3/22 to let her know that she should head to ER as the x-ray seemed to show fluid in her lungs.  After testing, lungs were shown to be clear and she was diagnosed with a pleural effusion.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient had Covid-19 after the 1st dose of Moderna/Covid in December, 2021) and PRODUCT DOSE OMISSION ISSUE (Has been more than 5-6 months since 1st dose/2nd dose not yet received) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2021, the patient experienced COVID-19 (Patient had Covid-19 after the 1st dose of Moderna/Covid in December, 2021). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has been more than 5-6 months since 1st dose/2nd dose not yet received). At the time of the report, COVID-19 (Patient had Covid-19 after the 1st dose of Moderna/Covid in December, 2021) had resolved and PRODUCT DOSE OMISSION ISSUE (Has been more than 5-6 months since 1st dose/2nd dose not yet received) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. No treatment medication was reported. Company comment: This spontaneous case concerns a 61 year old male patient with no reported medical history who experienced the unexpected non serious AESI of Covid-19 , unspecified days after receiving the first dose of mRNA-1273 vaccine. The patient is reported to have missed the second dose since the event. The Covid-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 61 year old male patient with no reported medical history who experienced the unexpected non serious AESI of Covid-19, unspecified days after receiving the first dose of mRNA-1273 vaccine. The patient is reported to have missed the second dose since the event. The Covid-19 pandemic could be a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient stated that she had not received any of the Covid Vaccines at any facility.  Our staff administered the vaccine and when entering her data we discovered the patient had already received both doses of the Moderna Vaccine from another facility.
I forgot to dilute the vial prior to administration of the vaccine. Patient received 0.2mL of undiluted Pfizer pediatric vaccine. This happened at 4:30 pm. I realized 1 hour later. I immediately called the parent and advised to monitor closely for any signs of adverse reaction or symptoms. Pharmacy staff will call patient's mother back tomorrow.
Experienced irregular, shortened, and lighter periods beginning 8/4. Pattern occured in Aug, Sept, and Oct. 3rd booster and ovulation experienced nausea. Reported symptoms to doctor. Was diagnosed with subclinical hypothyroidism after 5-8 years of taking no medication from Graves Disease hyperthyroidism once disease went into remission. My numbers have fluctuated toward hypothyroid without medication and stress events also more likely to make me hyperthyroid. For this reason, hypothyroidism feels rare and could possibly be linked to vaccine.  Note: Flu vaccine taken below on 7/12 is listed, but I have no idea which type and brand administered despite needing to choose an answer.
Local redness and swelling at site of innoculation; no throat swelling, generalized urticaria or wheezing. left deltoid. Tx Benadryl PO.
c/o numb feeling in lt elbow area & lt thigh lasting approx 2 wks;
i developed fever, chills, body aches and nausea.  it has been present for greater than 24 hours now
Received hepatitis A and B vaccines and TB testing at 12:15, at 1:30 felt hot and felt heart racing.  Was short of breath and face was swollen.  Resolved on it's own.  At 10 pm felt heart racing-resolved on it's own.
Nurse did an off site vaccine of this patient. Though software was indicating that she could not document Moderna, she thought that the reason she could not document Moderna was because she was off site, and there was a security issue, not because the patient was under the age of 18. She did contact the clinic admin about the error message, but had administered the vaccine before she heard back from her. Then was informed of the med error. Mom of patient was notified of med error by vaccinator, RN, and told to contact pediatrician to notify. Vaccine documented as being given in system. Vaccine department will be notified.
Pharmacy error: The Moderna vaccine with lot#003C21A that was sent out on 11/24/21 to our clinic should've the absolute expiration date of 12/17/21 and not 12/24/2021
2 hours after immunizations, groggy, lethargic, clingy, very fussy, pale, crying, "balance off", stopped eating at supper time. Restless during night. Temperature 101 - 101.6 continuing throughout weekend. Starting vomiting 12/28 (Wed) (day after), continued until Friday at noon 12/30. Sleeping a lot. Doctor called 12/29. Continued fussy, irritable, "red ears" - medication for possible ear infections - 1/1 Very fussy and low grade temp. 1/3 (Tues) eyes redding and mattered eyes. EEG ordered. "Getting better" by mom's report.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates on or after 11-MAY-2015, the patients were vaccinated with the improperly stored doses of PNEUMOVAX 23 (dose and route of administration were not reported) for prophylaxis. The excursion details were as follows: lot # K020214, expiration date 25-MAR-2016 - 31F or colder (23F) for 84 hours, 32F to 35F for 63 hours, 47F to 77F for 7 hours The nurse confirmed that all the vaccines were administered prior to their expiration dates. No adverse effects and no previous excursion were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA006088: US-009507513-1707USA008730: US-009507513-1707USA008731: US-009507513-1707USA008728:
Sudden onset of extreme swelling, itching, heat & painful to touch of the left elbow & forearm, not the original shot location.  After initial symptoms the swelling & pain got worse over next 36 hrs
Breakthrough case admission after 5 vaccines ; MOderna 2/8/21 Lot# 013M20A;  Moderna 3/8/21 Lot# 030A21A;  Moderna 1/31/22 Lot# 003J212A; Moderna 7/26/22 Lot# 017B22A;  Moderna 10/27/22 Lot# 050D22A
Dizziness (room spinning), fogginess in her head, trouble thinking clearly, and a heaviness in the back of her head/neck on the left side. She states she was having trouble speaking clearly. Friend who was with her states she seemed out of it and helped drive her home. Pt recently seen for recurrent self-resolving episodes 9 months later in May 2022.
Had pain in her left arm that extends in her neck and shoulders. Extremely tired and achy. Received physical therapy x2, used theraputty at home.
No pain, rash when went to bed 4/5/06. Woke at 05:30 AM swollen fingers hand to wrist with swelling upper deltoid and shoulder all on right side. Pain hand, elbow, shoulder right side. Used warm moist compresses, took ibuprofen, couldn't hardly move arm. Tried to work at home. Came into /// today. 4/7/06, right top of hand, fingers swollen slightly. Fingers tingling. Keeps loosing falling into shoulder hurts down to upper back when raises arm all right side. Injection site warmth, no redness, swelling, drainage. ///If any other symptoms or pain worsens to call and follow-up with doctor if necessary.
c/o swelling starting 11/8/99 PM;ice pack applied;pt denies fever c/o area hot to the touch,, edeam dec today approx 3" diameter, tender to touch @ the elbow;
This is a 74yo, Male, came to ER with - Had flu shot yesterday, this am developed rash right thigh, now diffusely spread to both legs, chest arm. Eyes feel matty. Chronic unchanged DOE. Physical exam - NAD General-ambulatory, awake, alert, oriented x3 HEENT- Normal, Lungs-clear, Heart- RSR. Extremities-Large, raised erythmous area medial right and left thigh, left axilla, diffuse small areas of same on chest and back. Assessment- Allergic reaction. Plan- Medrol DP and Loratidine.  5/1/09 ER report received for DOS 12/4/08 with DX:  Allergic reaction..  Pt presented with rash, itching and matty eyes one day s/p Flu shot. PE (+) for diffuse erythematous areas on back, thighs, axilla and chest. Tx:  Medrol and antihist.
Pt recvd 1st dose of vax on 30JUN92 & w/in 15 mins devel lightheadedness & nausea; pt was seen by MD; exam was nl; BP 132/94; pulse rate 76 & resp 12; MD felt that the pt's exp was related to the vax;
Woke up  8 days after vaccine to an approximate 2? round welt, red in color, and very itchy at injection site.  I took two Benedryl tablets that same evening, as of writing this , the welt has gotten slightly smaller but still very itchy.
Tested positive for COVID-19 after being fully vaccinated.; Tested positive for COVID-19 after being fully vaccinated.; This is a spontaneous report from a contactable nurse (patient, self-reported). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN5318 and expiry date was not reported), via Intramuscularly, in Arm Left, on 26Jan2021, as a single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN5318 and expiry date was not reported), via Intramuscularly, in Arm Left, on 16Feb2021, as a single dose for COVID-19 immunization at workplace clinic. The patient was not pregnant at the time of vaccination. The patient's medical history included diabetes and high blood pressure. The patient did not have known allergies. Concomitant medications were not reported. The patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Jul2021, the patient was tested positive for COVID-19 after being fully vaccinated. The events were resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included PCR test (nasal swab): positive on 24Jul2021. The patient received steroids and antibiotic tablets as treatment for the events. Outcome of the events was not recovered.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Information has been received from a physician concerning an 11 year old female who on 11-OCT-2007, received a 0.5 ml second dose of varicella virus vaccine live (Oka/Merck). Concomitant vaccinations included human papillomavirus vaccine (MSD), meningococcal ACYW conjugated vaccine (diphtheria toxoid) (MENACTRA) and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 13-OCT-2007, she developed itchiness, soreness, as well as being red and swollen down back of right arm to the elbow. The patient sought unspecified medical attention. It was reported that the physician recommended hydrocortisone cream and diphenhydramine (BENADRYL). Current patient status was not reported. A product quality complaint was not reported. No further information was available. Additional information has been requested.
Left Arm/Leg Numbness with Face Tingling Right Leg Numbness Numbness and Tingling continue
pt stated that she had some pain in left arm on 2/21/2021 that went away.  Then she developed swelling in the left arm on 2/22/2021.  On 2/23/2021 she noticed a red patchy ring around the injection site.  Pt called the medical clinic which told her to call us.
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. No information was provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies. On an unknown date (reported as "about two years ago" and "over 2 years ago"), the patient was vaccinated with a dose of GARDASIL (exact dose, dose number, route of administration, lot# and expiration date were not reported) for prophylaxis. On an unknown date, sometime after receiving GARDASIL (also reported as "over 2 years ago"), the patient developed inflammatory arthritis. The outcome of inflammatory arthritis was not reported. The causality assessment between the event and GARDASIL was not provided.
Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild
Red raised hot area 5 inches x 5 inches on right upper arm nausea/vomiting within 10 minutes of administration shortness of breath for 24 hours after administration chills and fever 102.4. Given Benadryl: Tylenol, Albuterol, Moist heat area.
I tested positive for COVID-19 on 1/24/23. I had fatigue, body aches, congestion, headache, and sneezing. This lasted for about a week. I contacted my doctor and was prescribed Paxlovid. I started to feel better within a day of taking Paxlovid.
blood clot; feels like there is a worm in between her ankle and knee, crawling around her leg; This is a spontaneous report from a contactable consumer (patient reported for herself) received from a Pfizer sponsored program. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: Unknown) via an unspecified route of administration on 15Apr2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. She felt like there was a worm in between her ankle and knee, crawling around her leg. She thought that it might be a blood clot and it might crawl going to her brain. She said she's been up all night and she put an elastic bandage on her leg so that it won't crawl going to her brain. The outcome of the event was reported as unknown.   Follow up attempts are needed. Information about lot/batch number has been requested
SWELLING OF THE ARM THE SIZE OF WIFE'S HAND AND REDNESS AROUND THE INJECTION SITE. PAINFUL. RECOMMENDED PATIENT TO APPLY ICE AND TAKE OTC IBUPROFEN FOR PAIN PRN AND TO KEEP MOVING THE ARM.