chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2021 at 8:52 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 8:52 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 78.63 years. Concomitant products were not provided. On 23-Mar-2021, the vaccine with batch number 019B21A was moved to fridge. On 27-Mar-2021, 20 vials were moved to the clinic. On the same day between 09 AM to 10 AM, vials underwent temperature excursion with temperature of 35 degrees Fahrenheit. On 28-Mar-2021 at 10 AM, 15 vials underwent temperature excursion with temperature of 35 degrees Fahrenheit. On 29-Mar-2021 at 10 AM, 20 vials underwent temperature excursion with temperature of 35 degrees Fahrenheit. On 30-Mar-2021 at 09 AM, 03 vials underwent temperature excursion with temperature of 33 degrees Fahrenheit.  The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 22-Apr-2021. It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit. Treatment medications were not reported.
Information has been received from a physician concerning a female patient in her 70s with no pertinent medical history and no allergy who was vaccinated with ZOSTAVAX vaccine (Oka/Merck) SC. There was no concomitant medication. The patient developed shingles on her arm. The patient sought medical attention and saw the physician. This is one of two reports from the same source. Additional information has been requested.
Information has been received from the mother of her 12 year old son with a previous Pyloric Stenosis surgery, who was vaccinated with a dose of MMR II a few months after recovering from the Pyloric Stenosis surgery. The reporter stated that she was convinced that the MMR II preceded his autistic traits. The mother noted she could even trace the differences in him through pictures of before and after his MMR II shot. Upon internal review Aspergers syndrome was determined to be an other important medical event. Additional information is not expected.
This spontaneous report as received from a nurse refers to an unspecified multiple patients of unknown age and gender. On an unknown date the patients were vaccinated with PROQUAD (Merck) (route, dose, frequency and lot # not reported) that was improperly stored. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
autoimmune iatrogenic diabetic amyotrophic lumbar plexitis; I got a walker and my legs are now about 60 percent useless; big pain in my knee, then hip; knee kept getting thrown out from underneath me; weight loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). The reporter is the patient.  A 68-year-old patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: GAIT INABILITY (disability) with onset 2021, outcome "unknown", described as "I got a walker and my legs are now about 60 percent useless"; LUMBOSACRAL RADICULOPLEXUS NEUROPATHY (disability, medically significant) with onset 2021, outcome "unknown", described as "autoimmune iatrogenic diabetic amyotrophic lumbar plexitis"; ARTHRALGIA (disability) with onset 2021, outcome "unknown", described as "big pain in my knee, then hip"; ARTHROPATHY (disability) with onset 2021, outcome "unknown", described as "knee kept getting thrown out from underneath me"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "weight loss".  Clinical course: The patient reported, "I got the Pfizer booster when it first came out. That night I got a big pain in my knee, then hip, then my knee kept getting thrown out from underneath me. I got a walker and my legs are now about 60 percent useless. My neurologist said my weight loss contributed, but the booster triggered an autoimmune iatrogenic diabetic amyotrophic lumbar plexitis. It's been a year and I have gotten no help after being crippled. I am 68 years old, for God's sake help me. I did not get Covid though."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
At first, a severe lingering pain in the arm (from the elbow to deltoid); so much so that I couldn't lift my right arm for several days after it onset; when the pain subsided, it was replaced with a constant (24/7) muscle spasm near my right elbow. Later (around 9/3 or 9/4), I noticed that my "taste" seemed off, but it has turned out to be a lack of feeling at the rear of my tongue & throat (I noticed, specifically, when I ate frozen yogurt ~ I couldn't feel the "cold"). Around this same time (9/3 or 9/4) I noticed that it seemed as though I had to put conscious effort into breathing. I can breath OK without thinking about it, but it's uncomfortable & causes me to cough occasionally, & has also caused light-headedness (as my O2 drops from shallow breath ~ I have an O2 monitor for my clot situation, but have been using it for this lately). As I didn't have a rapid heartbeat, my BP didn't change, & my chest hasn't hurt, I have not gone to the ER for myocarditis (I don't have the symptoms). With a past of lung damage, I can only assume it is an allergic reaction to the vaccine, causing my bronchial tubes (or similar) to inflame, making it harder for me to breathe. I am looking to become an EMT student, so I decided to get the vaccine. Prior to this, I've never had an issue with meds or shots. I'd like this to be noted at my pharmacy so that it doesn't interfere with my EMT pursuits.
Hard knot at injection site with soreness, and redness 2 days after vaccination. Per patient site symptoms decreased over 3-4 days and now infection site is hot, red, sore in area approximate 5 inch circular area of lt upper arm.
Hetpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 76 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event herpes zoster was not reported. The reporter considered the event herpes zoster to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Information has been received on 16-NOV-2017 from a lawyer and the executor of the estate of a deceased consumer (date of death and cause of death was not reported.) The patient was reported to be a male patient of unknown age. The patient's prior concurrent conditions, medical history and concomitant medications are unknown. On or about On 26-JUN-2015, the patient received ZOSTAVAX(lot number and expiration unknown), subcutaneous for its intended purpose: the prevention of shingles. As a direct result of the vaccine, the patient suffered from a Shingles outbreak, in addition to chronic pain, rash and lesions to various parts of his body. The patient did not have a Shingles outbreak until 11-NOV-2016. As a direct result of the vaccine, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of ZOSTAVAX, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient has incurred medical expenses and other economic harm as a direct result of use of ZOSTAVAX. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, medical and related expenses, and other losses and damages. Upon internal review, deceased was considered to be medically significant. Additional information has been requested. Reported Cause(s) of Death: deceased.
Pharyngitis; Sore throat; Sensation that his throat was closing up; This case was reported by a consumer and described the occurrence of pharyngitis in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th October 2020, the patient received the 1st dose of Shingrix. On 9th October 2020, 5 days after receiving Shingrix, the patient experienced pharyngitis, sore throat and throat constriction. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the pharyngitis and sore throat were unknown and the outcome of the throat constriction was recovered/resolved.   It was unknown if the reporter considered the pharyngitis, sore throat and throat constriction to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's daughter. The patient received 1st dose of Shingrix and had a sensation that his throat was closing up. The patient went to the emergency department and was diagnosed with a sore throat and pharyngitis, was given steroids, and discharged. The reporter stated that emergency Room visit required. The reporter did not consent to follow-up.
Patient on phone call follow-up noted having a fibromyalgia flare about 36 hours after vaccination that is still ongoing. Patient managing with current medications and has not seen provider for further steps.
Change in menstrual cycle. Within 5 days of vaccine, 1st menstrual cycle (bleeding) started. That menstrual cycle was 2 weeks early. Menstrual cycle has since occurred every other week, with bleeding lasting about 5 days each time. So 5 days actively bleeding, roughly 10 days not bleeding in between, and then cycle begins again. Menstrual cycle previously averaged every 28 days for at least 5 years consistently. Cycle is now increasingly more painful, heavy, passing clots, etc.
Bells palsy diagnosed 6/11/2021-went to local urgent care.   Stroke 12/28/2021 went to emergency room
Hair loss; Fever; Nausea; Redness in their right arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in their right arm), ALOPECIA (Hair loss), PYREXIA (Fever) and NAUSEA (Nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 02-Apr-2021, the patient experienced ERYTHEMA (Redness in their right arm), PYREXIA (Fever) and NAUSEA (Nausea). On 08-Apr-2021, the patient experienced ALOPECIA (Hair loss). On 05-Apr-2021, ERYTHEMA (Redness in their right arm), PYREXIA (Fever) and NAUSEA (Nausea) had resolved. At the time of the report, ALOPECIA (Hair loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included Vitamins. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Follow up received on 12-JUN-2021 contains no new information.
SHINGLES; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient have unknown medical history.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of shingles was not reported. This report was non-serious.
Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Additional Details: Patient got Pfizer Bivalent Covid vaccine today (his previous doses had always been Moderna) and his wife called to report that he had hives, swollen lips (no tongue swelling or problem breathing), and itchy palms. Wife stated that she gave him 50mg of Benadryl. He is prone to allergies, such as seasonal and tree nuts but has not had any adverse reaction to Moderna shots before. Pharmacist, told patient and wife to keep a close eye on swelling, hives and breathing and go to ER if wor
exacerbation of MS nerve pain; exacerbation of MS nerve pain; Headache; fever; chills; injection site pain; arm soreness; itching; rash; This is a spontaneous report from a non-contactable consumer (patient).  A 37-year-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8730), dose 2 via an unspecified route of administration, administered in Arm Left on 02Apr2021 16:00 (at the age of 37-year-old), as Dose 2, Single for COVID-19 immunization. Medical history included multiple sclerosis (ms) on an unknown date. Concomitant medication included gabapentin and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) for unspecified indication. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's historical vaccine included first dose of bnt162b2 (BNT162B2, Solution for injection, lot no: EN6205), dose1 at arm left on 12Mar2021,16:00 for COVID-19 immunization. The patient was not diagnosed with COVID-19, Prior to vaccination and since the vaccination. No allergies to medications, food, or other products. On 03Apr2021 10:30, the patient experienced exacerbation of MS nerve pain, headache, fever, chills, injection site pain, arm soreness, itching, rash. The events were not treated. The outcome of all the events was Recovering at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mom sends picture to APRN.  Pt has red, raised, warm to  touch area at vaccination site.  Pt.'s mom instructed to continue to use Tylenol and cold pack to injection site.  Go to nearest ED if any further concerns like redness spreading or SOB.  Mom verbalizes understanding.
Information has been received from a registered nurse concerning her 24 year old daughter with allergies to cephalosporins and no pertinent medical history who approximately 05-MAY-208 was vaccinated IM with the third dose of GARDASIL. There was no concomitant medication. On approximately 05-AUG-2008, "three month ago", the patient experienced joint pain three months after receiving the third dose. At the time of this report, the patient's joint pain persisted. No lab tests were performed. The patient did not seek medical attention. Follow-up call was made and the office confirmed that the patient reported was not the patient with the practice. Additional information has been requested.
no adverse event; improperly stored doses administered; This spontaneous report was received from a medical assistant, regarding a 4 year old male patient. The patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included diphtheria toxoid, pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (INFANRIX-IPV) and "FW".    On 19-SEP-2019, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) intramuscularly (IM), (dose, dose number and location of administration were not reported) (lot # S012472, expiration date 20-OCT-2020), for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The vaccine was exposed to a temperature of 25.61 degree Celsius from 19-AUG-2019 to 02-OCT-2019 as recorded by a digital data logger. There were no previous temperature excursions, however on an unknown date, the vaccine was exposed to a temperature from 9 to 25 degree Celsius (25.4 degree Celsius) for a time frame of 8290 hours and 30 minutes as recorded by a digital data logger. No adverse effects were reported.   This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1910USA012981: US-009507513-1910USA012349: US-009507513-1910USA012350: US-009507513-1910USA012351: US-009507513-1910USA012352: US-009507513-1910USA012353: US-009507513-1910USA012354: US-009507513-1910USA012355: US-009507513-1910USA012356: US-009507513-1910USA012357: US-009507513-1910USA012358: US-009507513-1910USA012359: US-009507513-1910USA012360:
the ringing in his ears got louder.; the ringing in his ears got louder.; This case was reported by a pharmacist via sales rep and described the occurrence of tinnitus in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included tinnitus.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, immediately after receiving Shingrix, the patient experienced tinnitus and condition aggravated. On an unknown date, the outcome of the tinnitus and condition aggravated were unknown.   It was unknown if the reporter considered the tinnitus and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that, after receiving Shingrix, the patient went out to his car and read the vaccine Information Statement (VIS).  The patient noticed that, there was a warning on it to let your healthcare provider know if you experience ringing in the ears (people sometimes faint after medical procedures, including vaccination. Sitting or lying down for about 15 minutes can help prevent fainting and injuries caused by a fall. Tell your provider if you feel dizzy or have vision changes or ringing in the ears). The patient went back into the pharmacy and informed them that immediately after receiving Shingrix, he noticed the ringing in his ears got louder.  No additional information regarding how long it lasted was available.
Within 48 hours developed tachycardia. With heart rate reaching 136 at rest. Tachycardia is intermittent.; This is a spontaneous report from a contactable physician reporting for self. This 37-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL3248) on 11Jan2021 05:30 PM (vaccine location=left arm) at single dose for COVID-19 immunisation. Medical history was none. No known allergies. Concomitant medication included apremilast (OTEZLA). No other vaccine in four weeks. It was reported that within 48 hours patient developed tachycardia. With heart rate reaching 136 at rest. Tachycardia was intermittent. Using propranolol currently to keep heart rate down, propranolol 10 mg, and titrated to 20 mg. The event resulted in Doctor or other healthcare professional office/clinic visit. Patient did not have COVID prior vaccination, and did not test COVID post vaccination.  The outcome of event was not recovered.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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.
Flu like symptoms; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms) 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 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 INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported No Treatment information provided   Reporter did not allow further contact