chrisvoncsefalvay/vaers-outcomes huggingface dataset:
cough; nightmares; delirium; it feels like a very violent flu; dizzy; fever for three days; Nausea; tiredness; This spontaneous case was reported by a patient and describes the occurrence of DELIRIUM (delirium) in a 58-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.     The patient's past medical history included Confusion (occurred s/p first dose of mRNA-1273; lasted 4 days), Weakness (occurred s/p first dose of mRNA-1273; lasted 4 days) and Tiredness (occurred s/p first dose of mRNA-1273; lasted 4 days).   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced FATIGUE (tiredness). On 03-May-2021, the patient experienced DELIRIUM (delirium) (seriousness criterion medically significant), INFLUENZA (it feels like a very violent flu), DIZZINESS (dizzy), NIGHTMARE (nightmares), PYREXIA (fever for three days) and NAUSEA (Nausea). On 05-May-2021, the patient experienced COUGH (cough). On 06-May-2021, DELIRIUM (delirium), INFLUENZA (it feels like a very violent flu), DIZZINESS (dizzy), NIGHTMARE (nightmares), FATIGUE (tiredness), PYREXIA (fever for three days) and NAUSEA (Nausea) had resolved. At the time of the report, COUGH (cough) had not resolved.            Concomitant product use was not provided by the reporter. Treatment medication included Advil.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
very dizzy, felt high/drunk/stoned for months, major headache ,confusion, loss of short and long term memory, unable to control my body, tremors, shakes, legs wouldnt move at times, major fatigue, vert weak, at times i couldnt even hold a cup. At times I couldnt get up out of a chair or a bed. neurological  functional movement disorder. I had pots previously but that added to this and made me worse. i have better days and really bad days.
Rash below the injection; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and developed rash below the injection site 3-4  days. The reporter consented to follow up.  The Pharmacist reported that she had no report information at the time of the call.
This spontaneous report was received from a medical assistant via office manger and refers to patient of unknown age and gender. On 02-SEP-2014 the patient was vaccinated with LIQUID PEDVAXHIB, (lot # K000331, expiry 23-OCT-2016, dose # and route unspecified), that was exposed to temperatures outside of the proper storage range on unspecified dates. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Temperature excursion; vaccine left in freezer (13F to 5F) greater than 2 weeks
Vaccination 7/25/2014. Right after vaccination, had headache and still present. Off and on, no medications. Vaccination site itchiness 7/25/2014 then itchy and redness starting 7/26/2014 up to now. Upper stomach discomfort starting 7/28/2014. Normal BM, urination. No fever/chills.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immune disorder (NOS).   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       This case was linked to MOD-2021-015815 (Patient Link).; Reporter'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.
A non-serious spontaneous report of a patient testing positive for flu B manifested with fever, cough and chest congestion has been received from a health professional concerning a four-year-old female, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither the patient's past medical history nor the concomitant medications were reported. The patient received FLUMIST on 20-Sep-2010. The child received FLUMIST and 56 days later tested positive for flu B. The reporter said that the patient came in the office on 15-Nov-2010 with fever, cough and chest congestion. The patient was tested positive for that day. The reporter stated that she thought the patient was "ok" since they had not heard anything further from the child's mother. The outcome of event remains unknown. Additional information was received on 28-Dec-2010 and was added to the narrative: Symptoms of Flu were reported.
Small rash one dot, then spread. Perioral dermatitis. Doubt related to vaccine.
MRNA COVID-19 VACCINE-ASSOCIATED BULLOUS FIXED DRUG ERUPTION; This is a literature report for the following literature source(s):  A 47-year-old female patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG ERUPTION (medically significant), 2 weeks after the suspect product(s) administration, outcome "recovered", described as "MRNA COVID-19 VACCINE-ASSOCIATED BULLOUS FIXED DRUG ERUPTION". Therapeutic measures were taken as a result of drug eruption.  Clinical information: After the 1st dose on her left deltoid, she developed persistent right arm pruritus from mid-forearm to wrist that gradually became well-demarcated and erythematous by day four. Rash improved within seven days of using hydrocortisone but left hyperpigmentation of the skin. Two weeks after receiving her 2nd dose on her left deltoid, the same location on her right forearm flared up with more pronounced pruritus, erythema and a few bullous lesions. Rash improved after a week of using hydrocortisone leaving behind hyperpigmentation; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2, and the reported event drug eruption cannot be excluded. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Symptoms- Hives on abdomen , face, neck, back both arms and both legs. Treatment- Diphenhydramine 12.5mg PO given in office and RX
14 days after last dose of RotaTeq, he vomited four times & had intermittent severe abdominal spasm manifested by writhing & arching & flatus.  No stool in rectum for 36 hours.  Ovoid mass palpable in RUQ, resolved when pain abated.  7/30/2008 ER rec dated 12/12/2007. Pt presented with episodes of back arching, screaming and drawing up of legs in pain after feeds, vomiting x4 as well as increased sleepiness. DX: Vomiting-resolved.  Emesis not bloody or green. BS (+). Abdomen soft.
devel chicken pox in oct95 p/ his 6 year old sibling recvd vax; a second sibling also devel chicken pox;
This spontaneous report was received from a 74 year old male patient, who is also a pharmacist, who refers to himself and whose concurrent conditions included drug hypersensitivity/drug reaction to MOTRIN and diabetes mellitus. In approximately 2006 (also reported as "about 9 to 11 years ago"), the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneously (lot # and expiration date were not reported) for prophylaxis. Other suspect therapies included sterile diluent. On an unknown date, the patient experienced musculoskeletal disorder. On 24-AUG-2017, the patient experienced shingles outbreak on an unspecified area of the body. The patient sought medical attention regarding the shingles outbreak by calling his primary care physician on the day of the report. No treatment was given. He reported that he had multiple computed tomography (CT) scans performed on unspecified dates due to orthopaedic problems (results were not provided). The outcome of musculoskeletal disorder and shingles outbreak was reported as not recovered/not resolved. The relatedness between the events and ZOSTAVAX was not reported.
Patient inadvertently received Moderna vaccine as the second dose but first dose given at a different location was Pfizer. Patient does not report experiencing any sign or symptoms.
Wed-3 hrs after shot started getting tired. Thurs-felt flu like sx. Fri-dizzy in the am, ate chick salad for lunch; then threw up-called office and was told to eat dry food. Felt like arthritic pain in hip. Site reaction-red spots.
Headache, Diarrhea, NauseaVomiting, fatigue, chills Narrative:  Other Relevant History:
No adverse effects reported for the patient; one dose of an improperly stored vaccine vaccine, PEDV AXHJB, was administered to one patient; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported.      On 06-SEP-2019, the patient was vaccinated with one dose of an improperly stored (product storage error) of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route of administration were not reported; lot number R021075 has been verified to be valid for haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB); expiration date 10-JUN-2021) as prophylaxis. No adverse effects reported for the patient.        The vaccine experienced the following temperature excursion: 54 degrees Fahrenheit (°F) for 3 hours and 30 minutes. Reportedly, there had been previous temperature excursions of 56 °F for 45 minutes. The digital data logger was involved.
arm got hard (feels like solid) to touch on her injection site; arm got itchy on her injection site; arm got swelling on her injection site; arm got tenderness on her injection site; arm got hot on her injection site; arm was bad; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm was bad), VACCINATION SITE WARMTH (arm got hot on her injection site), VACCINATION SITE INDURATION (arm got hard (feels like solid) to touch on her injection site), VACCINATION SITE PRURITUS (arm got itchy on her injection site) and VACCINATION SITE SWELLING (arm got swelling on her injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .     On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced LIMB DISCOMFORT (arm was bad). On 10-Jan-2021, the patient experienced VACCINATION SITE WARMTH (arm got hot on her injection site), VACCINATION SITE PRURITUS (arm got itchy on her injection site), VACCINATION SITE SWELLING (arm got swelling on her injection site) and VACCINATION SITE PAIN (arm got tenderness on her injection site). On 11-Jan-2021, the patient experienced VACCINATION SITE INDURATION (arm got hard (feels like solid) to touch on her injection site). The patient was treated with HYDROCORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (arm was bad), VACCINATION SITE WARMTH (arm got hot on her injection site), VACCINATION SITE INDURATION (arm got hard (feels like solid) to touch on her injection site), VACCINATION SITE PRURITUS (arm got itchy on her injection site), VACCINATION SITE SWELLING (arm got swelling on her injection site) and VACCINATION SITE PAIN (arm got tenderness on her injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
9 hours later, eye itching, redness, itching all over. Lasted a day. Minimal itching with second dose, more achy.
ITCHING; BLISTERS IN MOUTH; METAL TASTE; SHOULDER PAIN; NAUSEA; This spontaneous report received from a patient concerned a 61 year old of unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included demorol allergy, and concurrent conditions included gastroparesis diabetes. The patient experienced drug allergy when treated with pethidine hydrochloride, triamcinolone acetonide, morphine, and pegylated liposomal doxorubicin hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced itching. On 26-MAR-2021, the subject experienced blisters in mouth. On 26-MAR-2021, the subject experienced metal taste. On 26-MAR-2021, the subject experienced shoulder pain. On 26-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, itching, blisters in mouth, shoulder pain, and metal taste. This report was non-serious.
From telephone contact received on 07/03/2002, it was reported that a 19 year old female received Tetanus toxoid ad vaccine on 07/03/02. Lot number U0464AA. Pt immediately had a focal seizure with involuntary arm and leg movements and loss of consciousness for 30 seconds. Pt completely resolved.
A spontaneous report has been received from Physician concerning a male patient. Patient relevant history and concurrent diseases were not provided. Patient had been receiving FLUMIST quadrivalent (intranasal), started on an unknown date. Doctor explained patient thought the first dose was expired, then later found out it was not expired- after administering the second dose which was considered as overdose. Action taken with FLUMIST quadrivalent was unknown. The outcome of the event overdose was unknown. The reporter assessed the event overdose to be non serious.
Fluid on stomach; Loss of appetite; Nausea; Vomiting; Test positive with COVID19 virus; This spontaneous case was reported by a consumer and describes the occurrence of ASCITES (Fluid on stomach) in a 74-year-old male 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 Hypertension and Cardiac disorder NOS.  On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced COVID-19 (Test positive with COVID19 virus). On an unknown date, the patient experienced ASCITES (Fluid on stomach) (seriousness criterion medically significant), DECREASED APPETITE (Loss of appetite), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, ASCITES (Fluid on stomach), COVID-19 (Test positive with COVID19 virus), DECREASED APPETITE (Loss of appetite), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
Local Reaction: LUA with 13x16 cm redness and swelling, warmth, Temp 99.6. No pain was on ABX as well.
This 39 year old female presents with: 1. hyperlipidemia. The onset of hyperlipidemia was 2014. Additional information: Patient here to discuss labs and treatment options for hyperlipidemia. 2. Reaction after Tdap. Patient reports having a reaction to her tetanus injection she received 1 week ago. She had a Tdap 1 week ago, within a day, she states, her left arm became very swollen, hard, painful, red. The following day, Friday, the pain and swelling into her left axillary and lymph node areas. She states her lymph were enlarged, quite painful and the next couple days the pain spread across her left chest wall to her sternum. She felt "out of it, lightheaded, problems with weakness/balance". Over the last 3 days the pain has progressed to her low back and now is "working up my spine". She states the pain has progressed up to the back of her neck and now causing more headaches and migraine-like headaches. She reports having a similar reaction 9 years ago and, at that time, they blamed it on a flu shot because she had received a flu immunization and Tdap at the same time. She states she had the exact same reaction with back pain, body aches, which eventually, over the following 2 years progressed to chronic fatigue, nausea, vomiting, bouts of diarrhea, chronic pain, which, she states was severe for about 2 years and then seemed to improve. She feels that what she is having now is the exact same reaction and she fears that it's going to progress into more pain and balance problems. She has not had any fevers, syncope, palpitations, chest pain. Her main concern is that she feels like she is drunk when she walks and she is imbalanced and feels "out of it". She's also concerned about chronic pain returning. She has tried TYLENOL and heat to her arm which seem to help.
Fever lasting till morning, pain in arm (continued as of 10/07), dizziness/head fog for a full day after.
pt devel fever, chills, vomiting reportedly 5 1/2hr p/vax;sx persisted & was brought to hosp where pt was adm 13OCT96;blood cult drawn;result recv 16OCT96 showed salmonella;
A report has been received from a Health Professional concerning a Child patient of unknown gender, who has been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 milliliters, Once/Single administration for Drug use for unknown indication. FLUMIST Quadrivalent (Intranasal) started on an unknown date for Drug use for unknown indication. It was reported that the accidentally wrong vaccine was administered to the child patient. The outcome of the event of Child accidently given wrong vaccine is unknown. The report was considered to be non-serious by the company physician.
Swelling in lips, face, wheezing, and throat closing approximately 13 hours after dose administered. Blood in stool Abdominal pain Treated at local emergency room
waves of heat feeling; tachycardia; chest tightness; This is a spontaneous report from contactable physician via Pfizer Sales Representative. A 50-year-old female patient received bnt162b2, via an unspecified route of administration in 2020 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced waves of heat feeling, tachycardia, chest tightness 15 min after receiving the vaccine in 2020. Patient received several doses of steroid and was kept overnight in hospital and recovered. The outcome of events was recovered in 2020. Information on the Lot/Batch number has been requested.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, waves of heat feeling, tachycardia, chest tightness, there is a reasonable possibility that the events are related to BNT162 vaccine.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 reviewas well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Aches all over Body.  Temperature 101.  Chills.  Bad Headache.  This is Flu Shot.
22nd day temp 102 headache myalgias   nasal congestion resolved the 3rd day
first dose of Shingrix about 2 years ago and has not received the second dose yet; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of shingrix 2 years ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details provided as follows: The reporter was a pharmacy intern. The age at vaccination was not applicable for this report. Till the time of reporting, the patient had not received the 2nd dose of Shingrix, which led to incomplete course of vaccination. The Vaers details were reported for 1st dose. The reporter did not consent to follow-up.
Redness, warmth, hardening. Went to urgent care and was placed on anti-biotic and topical cream. Doctor called it cellulitis