chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022; No adverse event; administered 3 doses of the bivalent vaccine from a vial which had been punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 3 doses of the bivalent vaccine from a vial which had been punctured for more than 12 hours), PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 79-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 immunisation.     No Medical History information was reported.    On 16-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 3 doses of the bivalent vaccine from a vial which had been punctured for more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 3 doses of the bivalent vaccine from a vial which had been punctured for more than 12 hours), PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered 3 doses of the bivalent vaccine from a vial which had been punctured for more than 12 hours) and PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022).    Concomitant drugs were not reported. It was reported that the bivalent vial of 2.5 ml was initially stored in refrigerator on 09-Nov-2022 and post puncture was stored in room temperature for 20 hours. The vial was first punctured on 15-Nov-2022 around 2:30 pm and was administered on 16-Nov-2022 1 dose at 11:00 am and 2 doses at 01:00 pm. The vial did not underwent any temperature excursion. Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-674355 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-674355:same reporter
Patient reported neck pain on left-side, numbness in left arm, left 1st, 2nd, and 3rd digit numbness. Reports unexplained bruising to left upper back and left arm. Patient stated all symptoms started on 10/20/2021, 2 days after administration of vaccine. Patient seen by her PCP on 10/26/2021, 11/1/2021 and 11/5/2021. She reported she started on amitriptyline and a muscle relaxer, which she did not have the name readily available when calling the health department.
I've also have had the vaccine, recommended two shots and still got shingles/suspected vaccination failure; Still got shingles; Pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 22-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient still got bad case of shingles. The patient stated that, prescriptions medications helped but still suffered with pain. The patient suggested to read comments and if did not get vaccinations, got them. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as contact details were not provided.
Patient states his left arm became sore, swollen, red and hot, down to about the elbow. Saturday evening he had a fever. No fever Sunday or Monday. He states his urine is orange.
On August 20th my toes started going numb by the 22nd my entire foot was numb as well as my hands. I saw my primary care provider on the 24th where they diagnosed me with a pinched nerve giving me a 6-day dose of prednisone as well as an anti-inflammatory and prescribed PT which I did through Saturday Aug 29th when I became unable to barely walk on my own. I saw a spine Ortho on the 31st who immediately diagnosed it as being neurological and sent me straight to the emergency room where the attending ER doctor immediately suspected Gillian Barre syndrome. I was admitted. At that point I had numbness in my tongue and around my mouth.  The next day I was given a spinal tap to confirm GBS my protein level was over 400. A port was inserted into my neck and I started plasma pharesis that afternoon and it continued for 5 days. After completion of plasmapheresis I was discharged after being in the hospital for 6 days to outpatient PT. Since leaving the hospital on a walker I progressed to a cane and can now walk on my own short distances. I still have numbness and tingling in my feet and just a little in my hands.
generalized itchiness; mild throat swelling; Fingers are swollen; feet are swollen; Subjective itchiness in hands and feet; hand swelling; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (generalized itchiness), PHARYNGEAL SWELLING (mild throat swelling), VACCINATION SITE SWELLING (Fingers are swollen), JOINT SWELLING (feet are swollen) and PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME (Subjective itchiness in hands and feet) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Obesity and Goiter. Concomitant products included ALBUTEROL SULFATE for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PRURITUS (generalized itchiness), PHARYNGEAL SWELLING (mild throat swelling), VACCINATION SITE SWELLING (Fingers are swollen), JOINT SWELLING (feet are swollen), PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME (Subjective itchiness in hands and feet) and PERIPHERAL SWELLING (hand swelling). At the time of the report, PRURITUS (generalized itchiness), PHARYNGEAL SWELLING (mild throat swelling), VACCINATION SITE SWELLING (Fingers are swollen), JOINT SWELLING (feet are swollen), PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME (Subjective itchiness in hands and feet) and PERIPHERAL SWELLING (hand swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication not provided.
PROQUAD that had been stored outside of recommended storage range; No additional AE details; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history provided. Concomitant therapies included sterile diluent(MERCK STERILE DILUENT).    On an unknown date, the patient was vaccinated with an improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA (recombinant Human albumin), lot # U029147, expiration date 16-MAR-2023) for prophylaxis (dose, route and site of administration were not reported).   The administered dose of the vaccine experienced a temperature excursion of -58 Degree Fahrenheit to 5 Degree Fahrenheit with average of -7 Degree Fahrenheit for 2 hours and below -59 Degree Fahrenheit with average of -65.2 Degree Fahrenheit for 46 hours. Pharmacist would like to know when the patient could be re-vaccinated. No additional adverse event detail.  This is one case of some cases from same reporter.; Sender's Comments:  US-009507513-2204USA006370: US-009507513-2204USA006442: US-009507513-2204USA006506:
Fever range from 96.9 to 101 in the course of first  12 hours starting around 12 hours after vaccine. The 96.9 drop was after fainting with minimal warning signs.  Chills and sweats were worse than any vaccine or actual sickness that I have ever experienced (ten times worse than shot #2 for Covid and I had fever for 2 days with that).  Continue to have a manageable low grade fever 100 degrees on day2 ,  but the low fever was not normal for me.
Patient given anthrax vaccination instead of typhoid vaccination, IM L deltoid 0.5 mg. Patient experienced no adverse reactions. Patient contacted and informed.
PATIENT APPEARED AT PHARMACY WITH INFLAMATION, REDNESS, ITCHING, FEVER ON LOCATION OF INJECTION.  SHE STATED THAT THE IMMUNIZATION WAS PAINFUL AND BEGUN TO HURT. THE PATIENT ARRIVED 3 DAYS AFTER THE IMMUNIZATION WAS GIVEN  ON 06/13/22 .  PATIENT CONTINUED TO PUT ICE PACKS ON AREA TO LOWER TEMPERATURE. PATIENT ALSO STATE THAT SHE EXPECTED THAT THE IMMUNIZATION  THAT WAS GIVEN WAS LOWER THAT EXPECTED.
A few minutes post vaccination, patient complained of her ears burning, left arm was tingling.  Vitals taken, MD on site assessed patient, oral Benadryl given.  Patient remained in clinic for approx. 45 minutes.  Symptoms improved somewhat, reassessed by MD and was discharged to home via personal vehicle with spouse.
Sore throat and fever started 3/27/21 at 6pm and have lasted 3 days at this point. Patient thinks it is recurrent tonsillitis though.
Pain never left upper half of left arm for several days, couldn't move it or even let my shirt sleeve touch it.  Felt like my arm had been cut off.  Six days later it is starting to get back to normal.  For six days I have been having really weird headaches, pains all over in my joints and muscles and neck, chest, back, jaw, legs, etc.  The pains and discomfort keeps moving all around my body to different areas.  I feel just horrible.  Getting a sinus infection or something.  I haven't been sick for over a year and a half before Covid even started.  I HAD natural immunity before this vaccine and was extremely healthy.
Received vaccine on 01/25/05. On 02/22/05, reported to health unit with 5 day HX of shoulder pain (right) with finger tingling and numbness x 1 day. Went to PMD, heat advised without relief/ Received TX from a chiropractor x 3 weeks later for an unspecified length of time. Numbness to this site remained. He was referred to a neurologist and was DX with Brachial Plexitis; resulted after EMG and nerve conduction studies. Ongoing recovery.
Patient's mother reports spots all over body following vaccination with Varicella, Prevnar, and Hepatitis A on 04/13/2023  First developed low grade fever and then had rash that spread over torso Maculopapular rash along torso without blisters or facial involvement suspicious for varicella vaccine reaction vs acute viral exanthem
Pt vaccinated on 4/22.  Pt turned away for second dose on 5/24 when the patient reported lip swelling with the previous dose.  Unknown time frame post vaccination.  Noted in EMR 5/24.
About a month after the second injection (June 2021), I developed a chronic case of eczema on my hands, front of right ankle, which progressed to the eyelids and other body parts. This persisted until treated  on June 20, 2022 with topical corticosteroids. I had never had eczema previously.
It was a Monday and I had what I thought was a allergy reaction with runny nose, post nasal drip. and that went on for 2 days and on Wednesday I was worse and I took a home test and was positive and I called my physician on Thursday,  and they scheduled me a telehealth and I was prescribed PAXLOVID and after I started the PAXLOVID I started to feel better by the 30th.
heart attack; cytokine storm; inflammation; This is a spontaneous report from a contactable consumer reporting for a friend. A 61-years-old female patient received bnt162b2 (BNT162B2) at the age of 61-years-old, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 for COVID-19 immunization at the age of 61 years. After the second dose, the patient had inflammation, a cytokine storm, a heart attack and then died on an unspecified date. It was not reported if an autopsy was performed.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: heart attack; cytokine storm; inflammation
I started having hot flashes a couple weeks after receiving the 2nd does of the COVID-19 Moderna vaccine.  I am now having them all through the day and night.  I was not having any prior to the vaccines.  My primary care providers office said I needed to notify  as they are keeping track of possible side effects from the vaccines.
Chills for first 48 hours.  Arm muscle at injection site sore since injection, experiencing muscle weakness in that arm. There is a lump where the shot was administered. I cannot raise my arm and it aches and throbs. The aching is getting worse every day and radiates down my arm. It has been almost a week and I cannot lift things with my left arm. Muscle feels weak all the way up to shoulder. Cannot raise arm. Entire upper arm muscle sore and throbbing, worse every day. Constant ache and muscle weakness plus lump at shot injection site.
Experienced "Covid Arm" after the second injection, fairly substantial upper arm pain for 72 hours. Still experiencing slight numbness in lower arm currently.
Patient received redness on both legs and turned into a rash/ hives and also spread to her back. Patient was given 1/2 tsp. Benadryl and that helped.
11-10-08 12:45 TWINRIX 1.0 ml intramuscular right deltoid. Expired 7-18-10. Immediately became pale, complain on feeling warm all over" like eating hot peepers". Diaphoretic. Blood pressure 130/190 pulse 80 beats per minute. 12:16 no shortness of breath, no itchiness, or rash 13:00 blood pressure 138/192, pulse 80. stabilized in chair. 13:10 color pink, 10:10 feeling fine.
Report from patient "Within two hours of the injection I contracted a fever, chills, chest heaviness congested, achy joints and did not feel like eating or drinking anything.  Felt this way until about 8pm then all symptoms slowly subsided except the aching joints.  Aching joints slowly went away the next day."
There is a 7 x 7 cm erythematous, slightly warm, slightly indurated, and tender plaque on the left deltoid.
7:00AM, MORNING AFTER SHOT HAD BAD HEADACHE IN BACK OF HEAD. 12:00PM STARTED ALL OVER BODY ACHES AND SWIMMY HEAD. 3:00PM SO MUCH BODY PAIN, DIDN'T WANT TO MOVE AT ALL. 1:00AM, WOKE UP WITH HEAD FEELING LIKE IT WAS GOING TO BLOW UP DUE TO HEADACHE. BLEW NOSE AND BLOOD CAME OUT OF EACH NOSTRIL. HURT IN BODY AND HEAD UNTIL 6:00PM. FELT BETTER ATER THAT. ALSO, INJECTION SITE IS RED, SWOLLEN, AND VERY PAINFUL.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 67 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 14-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 14-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degree Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 and 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016.
Pt recv vax on 2/23/99; on 2/24/99 pt exp fever (105), erythema & swelling at vax site
This spontaneous report was received from a pharmacist, who referred to a 62-year-old male patient with no pertinent medical history. The patient had no drug reactions or allergies. On 23-SEP-2017, the patient was vaccinated with ZOSTAVAX in the right arm (lot# N013274 and expiration date: 04-JUL-2018; dose and route administration were not reported) for prophylaxis, which was reconstituted with sterile diluent (manufacturer unknown) (dose, route of administration, lot# and expiration date were not reported). On the same date, the patient also received PNEUMOVAX 23 injection, intramuscularly (lot# N020502 and expiration date: 08-FEB-2019; dose was not reported) for prevention of pneumonia and FLUARIX (dose, route of administration, lot# and expiration date were not reported), both in the patient's left arm, at separate sites. The patient's concomitant medications included LIPITOR. On 24-SEP-2017, the patient began experiencing fever, chills and the inability to lift or move his left arm. On the same date, the patient began taking BENADRYL, ADVIL and started applying ice to the affected arm, as a treatment. The patient sought a medical attention by calling the pharmacist. No laboratory diagnostic studies were performed. The patient did not recover from the adverse events at the time of this report. No product quality complaint was involved. The reporter considered the event of inability to lift or move his left arm to cause the patient a significant disability, because the patient could not move his arm.
I was positive for COVID-19 on 31DEC2022, I had a sore throat and cough, I was really tired and achy. I had some lost of appetite, I didn't have a fever. I called my doctor and got prescribed PAXLOVID, I started feeling better about 6 days after.
Information has been received from a nurse practitioner concerning a female who was vaccinated with a dose of GARDASIL and passed out immediately following her vaccination. The nurse practitioner could not confirm that these events were definitely related to vaccination with GARDASIL. The practice began observing the patient for 15 minutes after the patient received vaccination as a result of the event. This is one of three reports received from the same source. Additional information has been requested.
Pretty soon after receiving my first Moderna Vaccine I noticed a few spots, but have issues with eczema so didn't think much of it. After my second dose I noticed the spots spread quickly across my abdomen, sides (flanks), and lower back. It often encroaches on the top of my buttocks and upper back. It has been ongoing and persistent for 2 years with no reprieve. My dermatologist treated it first with triamcinolone, which only made things worse over time. It made my skin very scaly and even more itchy.  He then decided it was best to biopsy and the results came back as Grovers Disease. Next he tried prednisone and things got much, much worse that I had to expedite my taper. I had significant symptoms from prednisone including a lot of hair loss from my scalp. I have since stopped all treatments as it only made the condition more unbearable.   My current at home treatment is to use a sensitive soap or shea butter soap, Sarna sensitive lotion and ending with petroleum jelly as an occlusive to lock in the moisture. Although persistent, at times it can really calm down, but then then flare up with no warning and no changes in my treatment.  I began researching online about a year after onset and only saw one study linking grovers disease to Moderna -- it said Acantholytic dyskeratosi was mimicking grovers disease in Moderna patients. Then yesterday I saw an online thread where several women had mentioned the onset of grovers disease after taking Pfizer as well. I realized that I'm not unrealistic to link the disease with the vaccine and decided to report my symptoms in hopes they can find the connection and find reasonable cure or treatment plan to combat this vaccine side effect.
L arm cellulitis (swelling, erythema, warmth and tenderness), hospitalized 11/14 for signs of sepsis (fever, tachycardia, elevated inflammatory markers, agitation), treated with IV vancomycin + ceftriaxone followed by PO clindamycin + cefdinir. Required removal of Supprelin implant in L arm for concern of infection of this device.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Oct2021 at 14:30 as dose 3 (booster), single (Lot number: EW0217) at the age of 67 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing), notes: Type 2 diabetes; "high blood pressure" (unspecified if ongoing), notes: high blood pressure; "Known allergies: Sulfa antibiotics" (unspecified if ongoing), notes: Known allergies: Sulfa antibiotics. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Positive, notes: Positive test results on 30May2022 and 02Jun2022; (02Jun2022) Positive, notes: Positive test results on 30May2022 and 02Jun2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Anti-viral details: COVID 19 Treatment, Treatment start date: 20May2022 and stop date: 25May2022, Indication is used for treatment of COVID-19. Adverse event experienced on 30May2022 at 03:00 PM, Rebound COVID infection. Symptoms headache, sneezing, and sore throat occurred on 30May2022. Positive test results on 30May2022 and 02Jun2022. The outcome of event was not recovered without treatment.  No follow-up attempts are needed. No further information is expected.