chrisvoncsefalvay/vaers-outcomes huggingface dataset:
mononucleosis; This is a spontaneous report from a contactable consumer (mother). A 19-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller stated that her son was diagnosed with mononucleosis. The caller asked if her son could get the second dose of the vaccine. The reporter was calling to reschedule her son's second dose for the Pfizer Covid-19 vaccine because he missed the appointment for it. The caller was not sure when the first dose of the vaccine was given to him as the vaccination card was with her son. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a physician refers to a 78 years old female patient. The patient was vaccinated with ZOSTAVAX (Lot#, dose number, dose and route were unspecified) on 07-DEC-2007. No other co-suspects were reported. No concomitant medications were reported. It was reported that on an unknown date the patient showed up at the physicians office with shingles even though the patient received the vaccine in 2007. The patient had a rash around her waist area and no pain issues. The patient had sought medical attention via visiting physician office. No treatment was given for the AE. The outcome was reported as not recovered/not resolved. Additional information is not expected.
doses administered past the published expiry date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.
This spontaneous report was received from a pharmacist via field representative referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. In June 2012 (reported as "4 years ago") the patient received a dose of ZOSTAVAX (route unknown). No concomitant therapy was reported. On an unspecified time after receiving the vaccination, the patient developed redness at the injection site. The patient was seen in an unspecified emergency room on an unspecified date after receiving ZOSTAVAX for an unspecified reason and was diagnosed with shingles. The patient was prescribed acyclovir for treatment of the shingles on an unspecified date. It was not specified if the patient was admitted to the hospital. The outcomes of events were not reported. Additional information has been requested.
After receiving above vaccine on 2-19-19 about 2:34 PM, as I was getting ready to go to bed, I noted a headache, soreness of arm but went on to bed. Headache continued during night, along with soreness and muscle pain. When I got up the next morning, I took two TYLENOL, got ready to go to Mass but just wasn't feeling well at all, so made decision to stay home. I continued with headache, muscle aches, chills. Temperature was 100. I took two more TYLENOL about 10:00 AM. Now I have redness and swelling. (Time has run out).
This spontaneous prospective pregnancy report has been received from a nurse practitioner, for GARDASIL, a Pregnancy Registry product, concerning a 21 years old female patient with no persistent medical history and no drug reactions/allergies. The patient's history of previous pregnancies and live births was not known. The patient was intramuscularly vaccinated with a dose of 0.5 ml GARDASIL (lot # 667165/1167Z) on 10-OCT-2012. There were no concomitant medications. Subsequently, the patient became pregnant with an LMP on 13-AUG-2012 and an EDD of 20-MAY-2013. Initial exposure to GARDASIL was at 8 week(s). The patient was exposed to GARDASIL during trimester 1. The patient had sought medical attention via nurse practitioner visit. The patient performed urine pregnancy test. Additional information has been received from the nurse practitioner. Reporter stated that the patient delivered s healthy baby on 24-MAY-2013, with no complications. Physician stated that both the patient and baby were doing fine. Additional information is not expected.
Pt was vaccinated Hep B on 12/06/2001. On 12/07/2001 she developed a vaginal yeast infection, difficulty breathing and fatigue. On 12/10 called GYN and got diflucan and yeast cream. Recovered quickly after treatment.
Right after the shot I felt tired and a mild headache formed. However on May 29th in the evening, I became very very cold and my teeth were chattering very hard! Since then the fatigue has only increased, muscle soreness and my muscles have little strength as though I've done an intense workout and lactic acid has built up in the muscles causing fatigue. It might have been Monday or Tuesday when I felt pain in one ear and then the next. I have experienced sharp pain in my chest today. I had clear stool after getting the shot and diarrhea, which resolved. But today I have diarrhea again.
Pt. states 10 minutes after receiving vaccine she had severe pain from chest wall to both arms and across back. She could not bend over. Most pain on Rt side. Patient requested vaccine in L hip. She had mastectomy in 8/07, chemo and radiation 10/07/2008. Lymph nodes removed in arms. Was seen in ER on 11/4/09 and diagnosed with pleurisy and rx'd MOTRIN. She called because had no side effects with seasonal or PNE.
6/3/21 PMH COPD, RLL lung resection, CHF, HTN, DVT s/p IVC filter, factor V Leiden presenting for progressive dyspnea
numbness in her right thigh/outside of her right thigh got very numb; the area where she got the shot got very numb; itching all throughout her body/then itching started/the right side of her body is itching; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in her right thigh/outside of her right thigh got very numb), PRURITUS (itching all throughout her body/then itching started/the right side of her body is itching) and VACCINATION SITE HYPOAESTHESIA (the area where she got the shot got very numb) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053L21A and 053L21A) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), TOPIRAMATE (TOPAMAX), CLONIDINE and GABAPENTIN for an unknown indication.   On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-2021, the patient experienced HYPOAESTHESIA (numbness in her right thigh/outside of her right thigh got very numb) and VACCINATION SITE HYPOAESTHESIA (the area where she got the shot got very numb). In July 2021, the patient experienced PRURITUS (itching all throughout her body/then itching started/the right side of her body is itching). At the time of the report, HYPOAESTHESIA (numbness in her right thigh/outside of her right thigh got very numb) and VACCINATION SITE HYPOAESTHESIA (the area where she got the shot got very numb) had resolved and PRURITUS (itching all throughout her body/then itching started/the right side of her body is itching) outcome was unknown.            No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Significant follow up - patient demographics, concomitant drugs, 2 doses details, Event added .
Covid19 breakthrough.  1st vaccine on 04/25/2021.  Of note, pt was vaccinated outside the country and no lot numbers available, card in different language.  Pt is 56y/o with PMH of Diabetes Type2 who presents to ED with 2 day history of cough, SOB.  Room air sat 87%, pt required Heated High flow O2 100/40 and 15L NRB on top of that.  CXR with bilat perihilar and bibasilar patchy interstitial airspace opacities.  Started on IV Steroids/ ABX and Remdesivir.
PAIN IN EYE BONE; PAIN IN JAW/ HEADACHE LIKE PAIN INSIDE JAW BONES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, and expiry: Unknown)  0.5 ml, administered on 12-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced pain in eye bone. On 12-MAR-2021, the subject experienced pain in jaw/ headache like pain inside jaw bones. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in eye bone, and pain in jaw/ headache like pain inside jaw bones. This report was non-serious.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age, ethnicity, and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fever after administration in the pharmacy on an unspecified date. Outcome of the event was unknown. No follow-up attempts are possible; information about the batch number cannot be obtained.
Developed red, itchy raised bumps on my body that resemble chicken pox.  I also developed a constant taste of metal in my mouth.
Dizziness, Headache, Fever, NauseaVomiting, C/O feeling extremely tired, throat dry painful; arm paint at injection site; fever of 101.3; chills Narrative: Symptoms are improving. Employee stated f/u with pcp since hx of heart condition, symptoms of extreme tiredness was severe. Advise to seek emergency medical attention with worsening of symptoms, or if symptoms persist > 48 hours; update EH
dehydrated (always feeling thirsty); dehydrated (always feeling thirsty); fatigue; severe arm pain (injection site); severe arm pain/ Muscle ache; muscle aches and chills; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (dehydrated (always feeling thirsty)), THIRST (dehydrated (always feeling thirsty)), FATIGUE (fatigue), VACCINATION SITE PAIN (severe arm pain (injection site)) and MYALGIA (severe arm pain/ Muscle ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced DEHYDRATION (dehydrated (always feeling thirsty)), THIRST (dehydrated (always feeling thirsty)), FATIGUE (fatigue), VACCINATION SITE PAIN (severe arm pain (injection site)), MYALGIA (severe arm pain/ Muscle ache) and CHILLS (muscle aches and chills). At the time of the report, DEHYDRATION (dehydrated (always feeling thirsty)), THIRST (dehydrated (always feeling thirsty)), FATIGUE (fatigue), VACCINATION SITE PAIN (severe arm pain (injection site)), MYALGIA (severe arm pain/ Muscle ache) and CHILLS (muscle aches and chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Headache and fever on Friday 4/30/21 evening. On Saturday 05/01/21 she was fatigued, and she also noticed a small rash on her left arm at the site. Over the next several days the "rash" grew to the size of a baseball. The rash was raised, itchy, and very painful. She went to her PCP on Thursday 05/06/21 to have it looked at.
so tired she slept for 12 hours; This is a spontaneous report from a contactable consumer via medical information team. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, it was reported that the reporter knew someone who got the shot and said they were so tired she slept for 12 hours (2nd AE by same caller logged on different interaction). The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
I was doing penicillin, that was done blood work all came out negative my blood work doctor said she didn't know why my tongue was so bad
Patient had a rash all over the front side of his chest, he complained of only rash without itching that has progressively gotten worse. I told the patient to put hydrocortisone cream on it and contact the doctor right away.
No additional adverse effects reported; an improperly stored dose of VARIVAX was administered to a patient; This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, previous drug reactions, or allergies were not reported.  On 25-JUN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (vaccination scheme, anatomical site of injection and route of administration were not reported; lot number S025610, which has been verified to be valid, expiration date reported and validated as 18-AUG-2021) as prophylaxis (product storage error). No additional adverse effects reported.  The vaccine experienced a temperature excursion of 22.3 degrees Fahrenheit (F) for 4 hours and 25 minutes. There was a previous temperature excursion of 8.6F for 1 hour and 51 minutes, as recorded by a data logger.
Fever, Rash, UrticariaPruritus,  Axillary tenderness Narrative:
Fatigue, Migraine, Nausea, low-grade Fever - the day following the booster shot, I experienced these symptoms. The symptoms continued on the next day (Friday, 12/3). Fever, migraine, and nausea resolved by 12/4. 12/7 - began experiencing foggy brain. Very difficult to concentrate and retain information.
Itching hot spot; second dose was outside the recommended dosing interval; Itching hot spot; pain at the injection site on left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Itching hot spot), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was outside the recommended dosing interval), VACCINATION SITE PRURITUS (Itching hot spot) and VACCINATION SITE PAIN (pain at the injection site on left arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site on left arm). On 28-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE WARMTH (Itching hot spot), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was outside the recommended dosing interval) and VACCINATION SITE PRURITUS (Itching hot spot). On 08-Mar-2021, VACCINATION SITE PAIN (pain at the injection site on left arm) had resolved. On 28-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was outside the recommended dosing interval) had resolved. On 02-Jun-2021, VACCINATION SITE WARMTH (Itching hot spot) and VACCINATION SITE PRURITUS (Itching hot spot) had resolved.            Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Patient demographics, event verbatim was added.
Had a hot spot in my right palm that lasted 24-48 hours    I think pretty soon after for sure on my drive home from work I noticed  Right side of face felt funny then numb on cheek, whole side of right head top of scalp to jar and over to right ear x 8-10 days Sore arm, tiredness and fatigue  x10 days and some numbness in hand x5 days
No additional AE reported; MMR II and VARlVAX were reconstituted incorrectly using PEDVAXHIB and administered; This spontaneous report was received from a nurse referring to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant drugs and drug allergies were not reported.  On 09-APR-2021, varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T024287, expiration date expiration date was not reported, upon internal validation established as 15-JUL-2022, dose, strength, and route were not reported) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status recombinant Human albumin (rHA)) (lot # S039319, expiration date expiration date was not reported, upon internal validation established as 04-DEC-2021, dose, strength, and route were not reported) were reconstituted incorrectly using haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T026959, expiration date expiration date was not reported, upon internal validation established as 11-MAR-2023, dose, strength, and route were not reported) instead of diluent. And they were then administered to the patient (wrong solution used in drug reconstitution). There was no additional adverse event reported.
This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patients received doses of improperly stored PROQUAD lot# reported as M007963 with expiration date: 09-OCT-2017 (dose, route of administration and injection site were not reported). Administered doses of PROQUAD underwent temperature excursions at 12 Fahrenheit degrees, for 720 minutes. Previous temperature excursions was at 32 Fahrenheit degrees, for 750 minutes. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT HAD SWEAT, RACING HEART, ANXIETY WITH VACCINE AFTER ADMINISTRATION
Bronchitis; COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4163705-00 (AbbVie).  A 79 years-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 04Apr2021 (Batch/Lot number: unknown) at the age of 78 years as dose 2, single and intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 01Sep2021, outcome "recovered" (2021) and all described as "COVID-19"; BRONCHITIS (non-serious) with onset 15Nov2021, outcome "recovered" (2021), described as "Bronchitis". The patient underwent the following laboratory tests and procedures: chest x-ray: (15Nov2021) unknown results; (15Nov2021) unknown results, notes: Lung X-ray. The action taken for adalimumab was unknown. Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of COVID- 19 and BRONCHITIS FROM COVID-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility.  The reporter considered "covid-19" and "bronchitis" related to bnt162b2.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective, suspected covid-19 and bronchitis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
she had a delayed reaction; The area is Itchy when it comes out and itchy when it starts to fade out; Rash below the neck, upper tights, around left elbow, chest & back area; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (she had a delayed reaction), RASH PRURITIC (The area is Itchy when it comes out and itchy when it starts to fade out) and RASH (Rash below the neck, upper tights, around left elbow, chest & back area) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced SKIN REACTION (she had a delayed reaction), RASH PRURITIC (The area is Itchy when it comes out and itchy when it starts to fade out) and RASH (Rash below the neck, upper tights, around left elbow, chest & back area). The patient was treated with CORTISONE for Itching, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. At the time of the report, SKIN REACTION (she had a delayed reaction) outcome was unknown and RASH PRURITIC (The area is Itchy when it comes out and itchy when it starts to fade out) and RASH (Rash below the neck, upper tights, around left elbow, chest & back area) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. 14 days after the booster shot, the patient had a delayed reaction. She had a rash below the neck, upper tights and arm around left elbow, chest and back area. Looks like rosacea but it was not rosacea. The area was Itchy when it comes out and itchy when it starts to fade out.   This case was linked to MOD-2021-406092 (Patient Link).
Tenderness, redness over left thigh around site of injection (10cmx 14cm)noted 1 day after administration of vaccine. Will give Clindamycin oral.