chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever on 7/15/21 (temp 101.5), 7/16/21 (temp 101.5), 7/20/21 (temp 100.5) Vomited 7/12/21.  Rash noted on exam 7/20/21:  a few pink papules on right wrist. One skin colored papule on back of left shoulder.  One pink papule on right buttock.  A few faint pink papules below her mouth.
severe joint pains; sharp muscle pains; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (severe joint pains) and MYALGIA (sharp muscle pains) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ARTHRALGIA (severe joint pains) and MYALGIA (sharp muscle pains). The patient was treated with HYDROCODONE at an unspecified dose and frequency; Bed rest (Bedridden for 3 days) for Arthralgia and Bed rest (Bedridden for 3 days) for Myalgia. On 09-Feb-2021, ARTHRALGIA (severe joint pains) and MYALGIA (sharp muscle pains) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator
Paroxysmal atrial fib with flutter with RVR. Wide-complex tachycardia suspect supraventricular with aberrancy. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Chills and aches about 2 hours after injection. Fever of 100.8 until about 9 pm. Took Tylenol and ibuprofen. Woke up next morning feeling fine.
On 1/29 afernoon he had 1 emesis. Next day early AM he had 2 more episodes of emesis and at 6am his mother noticed that he was weak and with a funny walk (ataxia).
Information has been received from a registered nurse concerning a 63 year old female with a codeine allergy who on 20-OCT-2007 was vaccinated with a dose of ZOSTAVAX in the left arm. On approximately 29-SEP-2007 the patient was vaccinated with a dose of Influenza virus vaccine (unspecified) also in the left arm. On 22-OCT-2007, during a doctor office visit, the patient's left arm was hard, red and hot to the touch at the injection site. The patient was not recovered. There was no product quality complaint. Additional information has been requested.
I went for a run in the morning on December 8th, 2021, the first time since my vaccine two weeks prior. That evening I started experiencing some mild chest pain/tightness. It got somewhat better the next day. I was feeling better on the 10th of December and went for another run, but this time I felt more achy/wheezy while running, particularly while running uphill. The pain got progressively worse throughout the day until it was quite bothersome by evening. I didn't end up going into urgent care or the ER, but was in communication with my doctor. The pain was in my chest and felt like a tightening sensation, but I could press on my chest/ribs and that would help with the pain. I went to my doctor on Tuesday, December 14th where she examined me and did an EKG. She said I was most definitely having a reaction to the vaccine, and that it wouldn't be wise for me to get the second dose. She advised not stressing my heart and just giving it time to get better. My EKG was normal. So, I have waited and waited...I'm feeling much better now, but not 100% normal.
Redness, pain, heat. Referred pt to urgent care for exam, pt returned with rx for Cephalexin 500 mg bid x 7 days
Initial unsolicited report received from a physician on 10 August 2015. A female pediatric patient, whose medical history and concomitant medications were not reported, had received multiple shots at one time as per standard protocol of HIB and DTAP (batch number, dose, route of administration and site of administration were not reported for both vaccines) on an unspecified date. On an unspecified date after vaccination, the patient experienced urticaria twice. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of event was not reported. Documents held by sender: none.
patient let us know today that she had a reaction to the vaccine, Her arm was red and swollen and itchy. She went to the Emergency room and the md gave her benadryl and advised her this was a side effect of the vaccine and that the effect could last for 6 to 8 weeks
Myalgia with severe muscle pain in neck, shoulder, arm and back; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYALGIA (Myalgia with severe muscle pain in neck, shoulder, arm and back) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (chloroquine). Concomitant products included METOPROLOL, ROSUVASTATIN, CALCIUM, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE & HCTZ) and GABAPENTIN.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MYALGIA (Myalgia with severe muscle pain in neck, shoulder, arm and back). At the time of the report, MYALGIA (Myalgia with severe muscle pain in neck, shoulder, arm and back) outcome was unknown.            Treatment received for the event, was not provided.   Action taken with mRNA-1273 in response to the event was not applicable; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.  Myalgia is consistent with the product safety profile
Information has been received from a physician concerning a 57 year old white female with osteoarthritis, diabetes mellitus, hypertension, gastroesophageal reflux disease, smoker and ACTO's causing increased LFT's who in October 1988 was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine (lot 0986N), in the right deltoid. Concomitant therapy included. rabeprazole sodium (Aciphex), atorvastatin calcium (Lipitor), gabapentin (Neurontin), lisinopril (manufacturer unk), celecoxib (Celebrex), insulin lispro (Humalog), insulin glargine (Lantus), aspirin, vitamins (unspecified) and cyanocobalamin, On Nov 09 2004, in the afternoon, the patient experienced right upper arm pain, erythema, swelling, fever and chills. Subsequently, the patient recovered. There were no relevant diagnostic tests or laboratory data. The patient had no adverse events following prior vaccinations. No further information is available.
Patient experienced a syncopal episode; was evaluated by EMS. Recovered and denied transport to hospital.
Tested positive for Covid 19; Tested positive for Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 11 year-old male patient received bnt162b2 (BNT162B2), administration date 04Dec2021 (Lot number: FK5127) at the age of 11 years as dose 2 (tris), single and administration date 13Nov2021 (Lot number: FI0007) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Feb2022 21:00, outcome "recovering" and all described as "Tested positive for Covid 19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Feb2022) negative, notes: Nasal Swab; (07Feb2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical information: No other vaccine in four weeks, No covid prior vaccination and covid tested post vaccination was reported as yes.   The lot number for bnt162b2 was not provided and will be requested during follow up.
It was reported that a 64 year old female received a Fluzone SV '99-'00 vaccination on 11/6/99. Reportedly, on 11/8/99, the pt developed hives. Pt was treated with Tagamet-Kenalog-Medrol pack. From additional information received on 12/9/99, the pt received the Tagamet-Kenalog-Medrol pack on 11/10/99.
Site: Pain at Injection Site-Severe, Systemic: Tingling (specify: facial area, extremities)-Severe, Additional Details: Patient reported difficulty moving upper arm. Nerve pain in shoulder.
Occlusion of Retinal Artery Blood Thinner, Aspirin No outcome yet but it is hoped that the occlusion would be reduced or eliminated.
Had senior dose of flu shot on 10/08/14 at approx 4 pm. On morning on 10/09/14 woke up with swollen eyes. Used cold packs and BENADRYL. Lasted 4 days.
Red, itchy spots on stomach and side of torso. Appeared about 24 hours after first dose. Still visible over 48 hours after. Started out as what looked like itchy hives, now they?re just rough, red, itchy patches.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 92-year-old male patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020). On 24th February 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional information was received as follows: The reporter did not have all event details because another healthcare professional administered SHINGRIX to the patient (in an unknown deltoid). The reporter did not know how long after SHINGRIX that the patient developed the shingles. The patient was treated by their physician for shingles. The batch number reported for SHINGRIX (53982), did not exist and was updated to 539A2, as per sales database.
This case was reported by a pharmacist and described the occurrence of injection site soreness in a pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. On an unspecified date, the pt received an injection of Engerix B (544A4; not a valid lot number). At an unspecified time post-immunization, the pt experienced injection site soreness. The event resolved after an unspecified period of time. Additional info was received from the vaccine provider on 9/12/03. The nurse who administered the vaccine stated that approximately 50 staff members at the facility had been immunized. The nurse wrote, "Most, if not all of the staff here who receive Engerix B vaccine experience a level of discomfort ranging from mild to severe injection site pain during infusing of the vaccine into the muscle with the majority of the staff experiencing moderate to severe pain upon infusion." The nurse declined to provide information on the individual staff members.
Patients PCP called to advise that child had been seen overnight at the ER for febrile seizures.
Unable to breathe/Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 53-year-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number was not reported), dose 2 via an unspecified route of administration, administered in left arm on 25Feb2021 11:30 (at the age of 53-year-old) as dose 2, single for COVID-19 immunization.  Medical history included mild egg allergy. high blood pressure, and ex-smoker. Concomitant medications included paracetamol (TYLENOL); melatonin; ibuprofen; colecalciferol (VITAMIN D).  The patient had previously received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) administered in left arm on 28Jan2021 11:30 as single dose for COVID-19 immunization. No other vaccine in four weeks. No COVID prior vaccination. On 01Mar2021, the patient was unable to breathe. She experienced Shortness of breath. Went to doctor and ER. Lungs were clear. No infection. They cannot find reason why and said it could be reaction. Can't breathe while walking short distance inside house from room to room. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included Nasal Swab in emergency room: negative on 04Mar2021. The patient received no treatment for the event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021243170 similar report from same reporter
Severe pain on my right side under my arm and right half of chest.  Went to the ER did  CBC w/auto Diff, Comp Metabolic panel,  DDimer, Quantitative,Lipene , Quantative, Lipase level, magnesium level, tropinin - 1, UA WITH MICROPSCOPIC and reflex criteria for urine culture Urine culture reflex criteria Rsdiology XR Chest 1 View Frontal EKG/ Cardiovadcular Electrocardiography 12 Lead
This spontaneous report was received from a pharmacist who refers to a patient of an unknown age and gender. The patient's medical history, concurrent condition, drug and allergy history was not reported. The reporter stated that on 05-MAY-2017, the patient was vaccinated with an expired dose of ZOSTAVAX, (strength, route, dose, lote number and expiration date were not provided) for prophylaxis. In addition, it was reported that on the same date, "five minutes after receiving that expired dose, the patient also received a non-expired dose of ZOSTAVAX. The patient's concomitant therapy was not reported. No adverse effects were reported. Additional information has been requested.
The worst part is that I couldn't get out of bed for 3 days and was with a fever 102.7 being the highest.  The whole thing lasted for 6 days and I just tested negative today. I had a severe headache. Cough wasn't that bad. I was vomiting and couldn't hold down food. I had more head and stomach symptoms. Really dry eyes which is something I never had before.  Today I still have a little bit of a cough and dry eyes.
The patient seemed to have come down with Bells Palsy as diagnosed by ER physicians. They stated that the Zostavax vaccine could have been the probable cause or link to the condition.
4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing; the vaccine may have been refrozen; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing), PRODUCT STORAGE ERROR (the vaccine may have been refrozen) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing), PRODUCT STORAGE ERROR (the vaccine may have been refrozen) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing), PRODUCT STORAGE ERROR (the vaccine may have been refrozen) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (4 adult patients received expired original booster Moderna COVID-19 beyond 30 days after thawing) and PRODUCT STORAGE ERROR (the vaccine may have been refrozen).    Concomitant products were not reported.  The vial was initially stored in the refrigerator on 29-Mar-2022, and the vial was administered to patients on 13-Apr-2022, 15-Apr-2022, 22-Apr-2022. The vial did not undergo temperature excursion. The patient received expired original booster Moderna COVID-19 beyond 30 days after thawing and the vaccine may have been refrozen.  Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-694650 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-694650:Master case
Information has been received from a physician concerning a 4 year old pt who was vaccinated between 15 and 18 months of age, with a dose of varicella virus vaccine live. The physician reported that the pt subsequently developed breakthrough varicella characterized by a handful of vesicles. Unspecified medical attention was sought and it was unknown if treatment was required for the breakthrough varicella. Subsequently, the pt recovered from the breakthrough varicella. Additional information has been requested.
Initially received one-time J&J COVID vaccine on 03/16/2021 with no adverse effects. Patient reports as recommended by CDC he choose a different MFR for second dose, he completed Pfizer COVID vaccine on 11/18/21 as a second dose and experienced the following: -Completed injection at local pharmacy in late afternoon and a few hours later when at home, he developed sudden tingling, pins and needles in bilateral lower extremities (below knees and down). He reports it was not radiating perse, just sudden tingling all over. Symptom persisted throughout the evening and somewhat calmed the next day, but later in day returned. Tingling  feeling persisted. -Around 10 days after injection, pins and needles /tingling sensation then developed in bilateral upper extremities (both hands and forearms).  Patient reports it was around this day 10 that he also began to notice "loss of sensation" or "numbness" on bottom of both feet.  He was able to remain mobile and walking, but felt "uncomfortable"- "pad stuck on park of foot" feeling, also numbness. Constant.
Information has been received on 08-OCT-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 26-JUN-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 14-DEC-2015, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Pt stated had pustules after 1st dose of SHINGRIX and developed chickenpox after the 2nd dose. Is on allergy shots, and likely immunocompromised.
Vaccine given Monday 8/30/21. On Tuesday  anticipated side effects of second vaccine evident but appeared worse than expected. Unknown at the time Urine was turning brown and cloudy. Wednesday 13 year old appeared to be recovering from day after side effects. Friday September 3, 2021 went to an Urgent Care Facility for Pink Eye. Daughter mentioned to the doctor her urine was looking funny. Doctor took a urine sample and immediately told us to go to the Emergency Room tests needed to be done.  Medical Center tests were conducted showing  Cloudy and Brown Urine with significantly elevated levels of Protein Qualitative 100 and a large amount of blood in her urine.  Ultrasound showed normal . Dr. treated as infection.  Next week no change or improvement in urine so we went to Pediatrician, same test results and culture returned negative. Suspected Nephritis.  Tired to schedule appoint with Nephrologist earliest was middle of October.  Went to emergency room at UMMC same test results. Nephrologist sent us home kept doctor vist for October 5. Same results. Awaiting next Doctor visit 11/11/2021
Pt recv vax on 8/4/98; on same day pt exp redness &swelling of arm.  Pt seen by M.D.; tx=Motrin.  Within 12 hrs pt exp swelling &redness of arm distal to injection site to the wrist, fatigue, nausea &vomitting.
Soreness at injection site.; Chills over night; body aches; headache; fever; This is a spontaneous report received from a contactable consumer, the patient. A 35-year-old adult male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 3248), via an unspecified route of administration in the left arm on 23Mar2021 at 13:45 (at the age of 35-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history and no allergies to medications, food or other products (reportedly none that patient knew of). The patient had not received any other medications within 2 weeks of vaccination nor received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248) via an unspecified route of administration in the left arm on 02March2021 at 11:00(at the age of 35-year-old), as a single dose for COVID-19 immunisation.  The patient had not tested positive for COVID-19 since having the vaccine. The patient was not tested with COVID-19 prior to vaccination. On 24Mar2021 at 14:00, the patient experienced soreness at injection site, chills overnight, body aches, headache and 101 degree fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of adverse events. The clinical outcome of vaccination site pain, chills, general body pain, headache and fever was recovering.   No follow-up attempts are needed. No further information is expected.
Within minutes after getting the injection, patient developed hives on left arm. Soon after the urticaria spread to the neck and face and patient was becoming increasingly itchy. Patient was given an intramuscular injection of epinephrine and Dexamethasone
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 15Jan2021 as dose 1, single (Lot number: EL3248), in left arm, on 12Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 03Oct2021 as dose 3 (booster), single (Lot number: FF2589), in left arm and on 30Mar2022 at 18:00 as dose 4 (booster), single (Lot number: FK9896) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: ATORVASTATIN, start date: Apr2015, stop date: 07Jun2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jun2022, outcome "unknown", COVID-19 (medically significant) with onset Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Positive COVID test for the week up to this point. Therapeutic measures were taken as a result of vaccination failure, covid-19.