chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from literature on 16-Jan-2018. Abstract: Lichen planus is an inflammatory dermatosis with a prevalence of approximately 1%. Recent meta-analyses show that patients with hepatitis C virus have a 2.5 - to 4.5 - fold increased risk of developing Lichen planus. Lichen planus has also followed vaccinations and has specifically been attributed to the hepatitis B vaccine, the influenza vaccine, and the tetanus-diphtheria-acellular pertussis vaccine. We describe a case of Lichen planus in a hepatitis C virus-infected male occurring in temporal association with the administration of the tetanus-diphtheria-acellular pertussis vaccine. The patient's presentation was clinically consistent with Lichen planus and confirmed by biopsy. It is likely that many cases of vaccine induced Lichen planus have gone unpublished or unrecognized. In areas with high prevalence of hepatitis C virus infection, we may expect to see more cases of vaccine-induced Lichen planus especially in light of the updated Centers for Disease Control and Prevention tetanus-diphtheria-acellular pertussis vaccination recommendations. This case serves to educate healthcare providers about vaccine-induced Lichen planus and, in particular, the need to counsel hepatitis C virus-infected patients about a potential risk of developing Lichen planus following vaccination. We also reflect on current theories suggesting the T-cell-mediated pathogenesis of Lichen planus and the role that hepatitis C virus and toxoid or protein vaccines may play in initiating the disease. This case involves 34-year-old male patient who was vaccinated with single dose of ADACEL (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications was not reported. On an unspecified date, four week following the vaccination, the patient experienced eruption of Lichen planus. Lab serology was negative for HCV antibodies. Corrective treatment was not reported. The patient's event outcome was not reported. List of documents held by sender: none.
shingles; This spontaneous report was received from a lawyer and a female patient of unknown age regarding a case in litigation on 02-MAR-2022. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. In or around January 2015 the patient was administered with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving Zoster Vaccine Live (ZOSTAVAX), the patient suffered shingles (herpes zoster). As a direct and proximate result of using Zoster Vaccine Live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior using Zoster Vaccine Live (ZOSTAVAX). Also, experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions. As a result of the manufacture, marketing, advertising, promotion, distribution and or sale of Zoster Vaccine Live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence 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. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. At the reporting time, the outcome of the event herpes zoster was considered as not recovered. The reporter considered the event to be related to Zoster Vaccine Live (ZOSTAVAX).
A report has been received from a Health Professional concerning a 13 year old, Female patient, who had been receiving FLUMIST quadrivalent (intranasal), 0.2 milliliters, unknown. FLUMIST quadrivalent started on an unknown date. The patient experienced moderate to severe abdominal cramping and moderate to severe diarrhea. FLUMIST quadrivalent was continued. The outcome of the event of moderate to severe abdominal cramping and moderate to severe diarrhea was unknown. The report was considered to be non-serious.
Metallic taste; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Metallic taste). At the time of the report, DYSGEUSIA (Metallic taste) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-090193 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090193:case for husband
Tues: dizziness, nausea, numb lips Wed: dizziness, nausea, numb face Thurs: dizziness, nausea, numb face and all extremities, aphasia
Moderna Bivalent administered and within 45 minutes I experienced a hot flush feeling, chest pain, heart palpitations and high blood pressure (170/110). EMS was called to the Pharmacy administering the booster.
5 days after the vaccination patient exhibited right leg weakness. I had been carrying her all morning and when I set her down to walk she immediately fell forward. I picked her up and she attempted to walk and fell again. She appeared unable to use her right leg properly. I carried her a bit and set her down to walk again. She dragged her right leg and toes and tried to walk. Her leg appeared to give out or exhibit sudden weakness and she would fall. I drove 10 minutes and got her out of the car. She still exhibited leg weakness. She showed no signs of pain, just frustration. I took her to the ER. The leg weakness continued for about 3-4 hours from when I first observed it. She also had diarrhea and foul smelling stools since the vaccine. She also showed unusual irritability since the vaccine.
I have been experiencing extreme joint pain since 3 days after receiving the shot. The pain is 24/7. I have been to my PCP, a rheumatologist, and a holistic doctor to find a solution to the inflammation and pain. I've had extensive blood work done as well. I have another  appointment on 1/10/2020 with the rheumatologist to see if she can recommend something to get the pain and stiffness under control. This has affected every day of my life since the symptoms began. Most nights, it is difficult to sleep. When I first get up in the morning, the pain and stiffness are unbearable. I try to move around as much as possible so I do not stay stiff. I take daily naps due to the loss of sleep. Before the Shingrix vaccine, I was a healthy, very active, and energetic woman who exercised 5-6 days a week.
adverse reaction to DTP; fever 102-erythema, crying most of noc; pvt MD advised give ped DT in future;
Dropped dead of a heart attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Dropped dead of a heart attack) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 MYOCARDIAL INFARCTION (Dropped dead of a heart attack) (seriousness criteria death and medically significant). The reported cause of death was Heart attack. It is unknown if an autopsy was performed.            No concomitant medication was reported. No treatment information was reported.  It was reported that patient's funeral was on 11 May 2021.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD21-090166, US-MODERNATX, INC.-MOD-2021-128463, US-MODERNATX, INC.-MOD-2021-128999 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD21-090166: US-MODERNATX, INC.-MOD-2021-128463:Same reporter US-MODERNATX, INC.-MOD-2021-128999:; Reported Cause(s) of Death: Heart attack
AT ONE OF OUR OFF SITE VACCINATION CLINICS, HE STATED THIS WAS HIS FIRST COVID VACCINATION. HE WAS GIVEN PFIZER AND RELEASED TO HOME. WHEN IT WAS BEING ENTERED INTO THE STATES DATABASE, MCIR WE LEARNED ON DECEMBER 28, 2020 HE RECEIVED MODERNA FROM  PHARMACY, LOT NUMBE3R 025J20A.
Pt returned to clinic for PPD read, c/o redness, sore arm X 1-2 days, upon exam red area at site of injection very warm to touch.  Advised pt to see physician pt refused.  No treatment administered.  Advised pt if worsens to go to ER.
post herpetic neuralgia; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an currently 78-year-old female patient (pt). Information about concurrent condition, concomitant medication or medical history was not provided. On or about 16-SEP-2015, the pt was administered the Zoster Vaccine Live (ZOSTAVAX) vaccine at her local pharmacy (strength, dose, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. Subsequently on an unknown date, pt was treated by a provider for the following injuries resulting from Zoster Vaccine Live (ZOSTAVAX) use: herpes zoster and post herpetic neuralgia. Pt claimed following damages as a result of Zoster Vaccine Live (ZOSTAVAX): injury to herself, loss of services and economic losses. The outcome of events was not provided. The causality was assessed as related by the lawyer and patient.
Swelling, pain, itching, in a 5" diameter circle around injection site. Mild fever 24 hrs. later.
Anxiety, shaking, restless, progressing to marked weakness of extremeties and face, slurred speech, slow thoughts.
got the vaccine and had a severe reaction to it; Immediately after having the vaccine had flu like symptoms/A flu-like reaction/Flu like symptoms lasted a couple days, 2 days; with a high temperature/ had a temperature of 104.5 for a couple of days; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (got the vaccine and had a severe reaction to it), INFLUENZA LIKE ILLNESS (Immediately after having the vaccine had flu like symptoms/A flu-like reaction/Flu like symptoms lasted a couple days, 2 days) and PYREXIA (with a high temperature/ had a temperature of 104.5 for a couple of days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (got the vaccine and had a severe reaction to it), INFLUENZA LIKE ILLNESS (Immediately after having the vaccine had flu like symptoms/A flu-like reaction/Flu like symptoms lasted a couple days, 2 days) and PYREXIA (with a high temperature/ had a temperature of 104.5 for a couple of days). At the time of the report, VACCINATION COMPLICATION (got the vaccine and had a severe reaction to it), INFLUENZA LIKE ILLNESS (Immediately after having the vaccine had flu like symptoms/A flu-like reaction/Flu like symptoms lasted a couple days, 2 days) and PYREXIA (with a high temperature/ had a temperature of 104.5 for a couple of days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104.5 (High) temperature of 104.5 for a couple of days.     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 medication was provided.  The reporter added that the patient is about 40 to 50 years  No treatment medication was provided.
Information has been received from a nurse referring to a 17 month old patient of unknown gender. Information about patient's current condition or medical history was not reported. The nurse reported that the patient received the first dose of M-M-R II (lot# not reported, 0.5ml, subcutaneously), at 14 months of age, on 18-DEC-2014 and the second dose of M-M-R II (lot# not reported, 0.5ml, subcutaneously), at 17 months of age, on 23-MAR-2015. No adverse effects were reported. Additional information has been requested.
a. Aches, pains, high fever--103 for two days b. Onset of cold like symptoms-Still occuring c. Large swelling and pain at injection site-Has still not returned to normal after one week.
FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 19-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Delayed side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (Delayed side effects) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (Delayed side effects). At the time of the report, ADVERSE REACTION (Delayed side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided    Reporter did not allow further contact
1420 - c/o headache, tongue hurts, arm @ injection site. BP - 116/8, P-100, R-16. Left with grandmother @ 1500 - home.
Arms to whole body trembling episode then same day: head and arm jerking (L>R) approximately 6-8 times during day (no loss of consciousness). Referral to pediatric neurology.
Polymyalgia Rhuemetica; This case was reported by a consumer via interactive digital media and described the occurrence of polymyalgia rheumatica in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant). The patient was treated with steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the polymyalgia rheumatica was recovered/resolved.   The reporter considered the polymyalgia rheumatica to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient reported that the shingles vaccine gave polymyalgia rhuematica a listed side effect. The patient took 30 months of steroids to get it in remission. The patient could not take vaccine because they could trigger it out of remission, not good during a pandemic . The patient wish that had never taken the shingles vaccine. The contact details of patient was not reported hence follow-up not possible.
1) Crushing chest pain @ 4 hours later for 4 hours. 2) Welts developing @ 24 hours later. 3) More welts @ 36 hours later, seen at ER, received antibiotics and was told of possible embolism. 4) Additional welts @ 72 hours, seen by MD, chest x-ray and increased antibiotics.
rash all over his body; potential allergies to ingredients in the Pfizer Covid 19 vaccine; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history included diabetes mellitus. The patient's concomitant medications were not reported. On an unknown date, the patient experienced rash all over his body and potential allergies to ingredients in the pfizer covid 19 vaccine and had to receive and Epi shot in response to some other unknown agents as well. Despite seeking clarification, caller was unable to identify his allergic reactions to an identified agent/drug. Explained he had a list of ingredients, noted .45ml of excipient. Consumer was interested in receiving vaccination. The outcome of the events was unknown. There was no product quality complaint (PQC) present.  The lot number for bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) was not provided and will be requested during follow up.  Follow-up activities closed. Batch/lot number not available for vaccine/BNT162B2.
1) WHEN HE CAME FOR HIS 2ND DOES HE RECEIVED MODERNA INSTEAD OF PFIZER. HE DIDN'T REALIZE IT UNTIL AFTER THE SIDE EFFECTS STARTED. HE DOES UNDERSTAND THAT THE SERIES IS COMPLETE. 2) HIS WIFE WOKE HIM UP  BECAUSE HE WAS BREATHING DIFFERENTLY. TEMP AND O2 ARE  BELOW. HE STAYED HOME FROM WORK UNTIL THE SYMPTOMS SUBSIDED, SO ABOUT 2 DAYS HOME.  NOTE: HIS 1ST DOSE WAS ON 3/3/21
My left hand developed severe pain, throbbing, numbness and tingling a few days after receiving my 2nd vaccine.
Shortness of breath; Allergic reaction; Rapid heart beat; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), HYPERSENSITIVITY (Allergic reaction) and TACHYCARDIA (Rapid heart beat) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion medically significant), HYPERSENSITIVITY (Allergic reaction) (seriousness criterion medically significant) and TACHYCARDIA (Rapid heart beat) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (Shortness of breath), HYPERSENSITIVITY (Allergic reaction) and TACHYCARDIA (Rapid heart beat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: rapid (High) rapid heart beat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company Comment: This case concerns a patient of unknown age and gender with serious unexpected events of hypersensitivity, dyspnoea, and tachycardia. Event onset with unknown latency after mRNA-1273. Outcome unknown. Rechallenge not reported. Reporter causality not provided. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender with serious unexpected events of hypersensitivity, dyspnoea, and tachycardia. Event onset with unknown latency after mRNA-1273. Outcome unknown. Rechallenge not reported. Reporter causality not provided. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Flushing in the face, shaking, heartbeat racing, and difficulty breathing. EMT took vitals, 92 heartbeat and 140/95 blood pressure. Drank water and rested. Symptoms decreased significantly within 30-45 minutes.
Within 12 hours, severe pain at injection site, weakness, headache, body aches, fever of 102.9 (at midnight), fever was reduced to 101.9 and remained there for the next 10 hours, then dropped to 97.6 and elevated again to 100.9, remaining there throughout the day. treated with bed rest, cold compresses on head, neck, wrists, acetaminophen, and liquids.
This spontaneous report as received from a medical assistant refers to a patient of unknown age.  The patient was administered the first dose of GARDASIL (dose, frequency, route and indication not reported) on an unspecified date in 2010 and the second dose in series "on time" on an unspecified date. Patient was in the office to receive the third dose in GARDASIL series on 13-AUG-2013. No adverse effects were reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
arm was sore; chills; a little headache; teeth were rattling; injection site had a little bump; a little bit of hurt; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (arm was sore), VACCINATION SITE SWELLING (injection site had a little bump), VACCINATION SITE PAIN (a little bit of hurt), CHILLS (chills) and HEADACHE (a little headache) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE SWELLING (injection site had a little bump) and VACCINATION SITE PAIN (a little bit of hurt). On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), CHILLS (chills), HEADACHE (a little headache) and CHILLS (teeth were rattling). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm was sore), VACCINATION SITE SWELLING (injection site had a little bump), VACCINATION SITE PAIN (a little bit of hurt), CHILLS (chills), HEADACHE (a little headache) and CHILLS (teeth were rattling) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.