chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of administration of expired product was received from a health professional concerning a nine-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 05-Feb-2012. The patient received FLUMIST either on 07-Feb-2012 or 08-Feb-2012. There was no adverse event associated with this mediation error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Developed severe OCD, tics catatonia, psychosis and auto-immune encephalitis. Was hospitalized for over 2 months. No pre existing conditions or health problems.
Red lump in the LVL size of 5 cm x 4 cm. Inflammatory reaction to the vaccine.
The patient was administered a volume of 0.25mL instead of the appropriate volume of 0.5mL. The error was recognized the following day and outreach was made to Moderna and CDC for clinical recommendations for the next step. Upon response from the clinical team 9 days later the patient was informed of the error and was given the direction to return to the pharmacy at as soon as possible to receive a complete dose of 0.5mL. No adverse event had been reported. Correct dose was administered on 09-18-22
threw up; absolutely wiped out; could hardly walk; very short of breath; chest pain; extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (threw up), FATIGUE (absolutely wiped out), GAIT INABILITY (could hardly walk), DYSPNOEA (very short of breath) and CHEST PAIN (chest pain) in an 85-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 No adverse event.  Concomitant medications were not reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.  On 19-Feb-2021, the patient experienced VOMITING (threw up), FATIGUE (absolutely wiped out), GAIT INABILITY (could hardly walk), DYSPNOEA (very short of breath), CHEST PAIN (chest pain) and FATIGUE (extremely tired).   At the time of the report, VOMITING (threw up), FATIGUE (absolutely wiped out), GAIT INABILITY (could hardly walk), DYSPNOEA (very short of breath), CHEST PAIN (chest pain) and FATIGUE (extremely tired) outcome was unknown.      Treatment medication include Ibuprofen.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Initial injection site felt a lot of pressure and at first there were mild symptoms of ringing in the ears and mind fogginess. Within 5 minutes after receiving injection I got up and walked less than 10 feet when I began experiencing extreme dizziness, ringing in the ears, lightheadedness, felt warm, and began to feel chills/tingling throughout my whole body but especially in my head.  I ended up passing out and was unable to sit up in a chair without assistance. For about 10 minutes I was profusely sweating all over my entire body, had continued chills/tingling, difficulty breathing and was semi coherent. The nurse at the pharmacy had me sniff ammonia salt and gave me water to help. I waited for 20 more minutes before finally feeling able to get up and walk around the store. Body chills and cold sweats continued for a while but no further symptoms at this time (2hrs after vaccination).
On 6/1, arm started swelling at injection site.  Got very swollen, hard and painful.  About 7 inches in diameter.  By 6/8, the swelling had gone down significantly but hard knot is still present on 6/12.  On 6/2, it became very swollen under the armpit on the injection side arm. Armpit was swollen and painful until June 7th.
Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included APIXABAN for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication details was reported.
Inappropriate schedule of vaccine administered; slept for an entire day and could not stay awake; extremely cold; back went stiff; in pain for a week; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 30Sep2021 (Batch/Lot number: unknown) at the age of 48 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "dairy allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Benadryl, reaction(s): "drug allergy". Vaccination history included: BNT162B2 (Dose Number: 1, Batch/Lot No: Unknown. , Location of injection: Arm Left), administration date: 16Sep2021, when the patient was 48 years old, for COVID-19 immunisation, reaction(s): "numbness in the legs where they hurt and started swelling", "numbness in the legs where they hurt and started swelling", "numbness in the legs where they hurt and started swelling". The following information was reported: SOMNOLENCE (non-serious) with onset 2021, outcome "recovering", described as "slept for an entire day and could not stay awake"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "recovered" (2021), described as "extremely cold"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "recovering", described as "back went stiff"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "in pain for a week"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 30Sep2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered".  Additional information: This report was received via reporter. The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient did not receive other vaccine in four weeks. The vaccine was administered in Pharmacy or Drug Store. Clinical Course: After the 2nd dose, patient slept for an entire day and could not stay awake and was extremely cold, it took 2 days for this to pass, then my back went stiff and in pain for a week. The events were reported as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
new onset severe thrombocytopenia, unexplained by extensive hospital work-up by hemotologist
Note of nurse 1-6-12 "Pt came into have PPD read- neg. Stated got a reaction from the pneumococcal vaccine. His (Rt) arm got very red & hard. He ran a T of 103. He went to ER. He was given some medication & discharged. T at hospital 98.1. Both arms still red." Accompanied by wife.
12 hours post-injection patient experienced fever (100 degrees F), headache, lethargy, significant pain at injection site, chills, aching joints, and painful swollen lymph nodes in the armpit of the arm the injections was administered in. Symptoms resolved by about 36 hours post-injection. Only remaining symptom at 4 days post-injection is swollen lymph nodes, no longer painful.
Headache, Myalgia, Fever, NauseaVomiting, chills, pain in the left arm, tired Narrative:  Other Relevant History:
Child received Tdap, Varicella, Menactra and HPV #1 on 09/11/07. On 09/13/07 she woke up with angioedema of face. There was no difficulty breathing or swallowing. There was no seafood or nut ingestion. She took Motrin the night before and was hospitalized. Received IV steroids and discharged home the next day. 10/15/07-records received for DOS 9/13-9/14/07. DC DX: Angioedema. On day of admission noticed face swollen, with significant swelling of lips and lower face causing disfiguration and drooling.  Self treated with Motrin. DC instructions include avoid Motrin and follow up with allergist
arm @ inj site-to elbow red, swollen, hot, red, nauseated, almost fainted;
his teeth got swollen, then red and purple after; left shin was a little red; left foot red, purple, and swollen/right foot red and purple; left foot red, purple, and swollen/right foot not as swollen; This is a spontaneous report from a contactable consumer or other non Healthcare Professional. A 57-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9264),via an unspecified route of administration on 05Feb2021 as single dose for COVID-19 immunisation. Patient medical history included paralysis since 28Aug1996, patient concomitant medications were not reported. On 06Feb2021, The patient reported that his left foot red, purple, and swollen; patient right foot red and purple (it was reported that right foot not as swollen). The patient reported that he got his first shot last Friday, 05Feb. He says that he is a police officer that has been paralyzed for 24 years and after he got the first dose last Friday, on Saturday his left foot swelled, then Sunday it swelled some more. Patient said he walks with therapy using an exoskeleton and they noticed also that it was purple, red, and swollen. Patient said a couple days later his right foot started turning purple and red, but was not as swollen. He says that he has heard that for people who suffer from blood flow problems with circulation there was a problem after the shot, this is something he has never had in 24 years so he would like to know if it is related to the injection. No further details about others who were receiving vaccine provided. Patient reported that it was only his feet, though his left shin was a little red yesterday. Patient said that his second injection was coming up, and he would like to know, is that going to do it again, because he can't do therapy when that happens. Patient reported that his swelling was bad but then it got better. He says after the half hour drive to the hospital for therapy both feet got worse, and this morning his left is still swollen but his feet are better, he will see at the end of the day what it is like. Patient said that his doctor's office took blood tests and did an ultrasound for the circulation of his leg, the patient underwent lab tests and procedures (on unspecified dates) which included Blood test: possible blood or leg infection and Ultrasound scan: possible blood or leg infection. Investigations: Patient reported that his doctor said that his labs were clear and that his ultrasound was clear. Therapeutic measures were taken, patient was prescribed antibiotics for a possible blood or leg infection. No further details provided about the antibiotics prescribed for treatment. The outcome of the events left foot red, purple, and swollen/right foot not as swollen were recovering, however clinical outcome of other events were unknown.  Follow-up attempts completed. No further information expected.
Patient with left arm pain that started after vaccination, and continued after 6-7 weeks. Has improved over time, but will need physical  therapy.
On 9-14-06 The child received 4 vaccines at approximately 10:45 am.  At approximately 10:45 pm, mother heard her cough while she was sleeping in her crib, about 5 minutes later I heard her cough again.  She had not been sick so I was concerned.  I went to her room she was wide awake smiling and babbling.  I picked her up and played with her for about 5 minutes. I then breast fed her and realized she was only nibbling and not eating like normal.  I then put her her back into her crib and not 30 seconds later she vomited.  I pick her up and sat her on the floor so I could change the bedding as soon as I was done changing it.  I picked her up and she started to vomit again.  I called for my husband to come and help.  As he was cleaning up I went to get the pamphlets that talk about adverse reactions.  I noticed on the DTaP that 1 in 50 children will vomit.  About 10 minutes later she started vomiting again.  At that point I was concerned, but not worried.  She continued to vomit until she was having dry heaves and had completely emptied her stomach.  I took her to bed with us and I breast fed her again around midnight and she was fine.  No more vomiting episodes.  The next morning I called the doctor's office to report the adverse reaction.  I spoke the nurse and explained to her what had happened.  Her first comments were that the child had some kind of viral thing.  I then told her about the 1 in 50 children vomiting and she said well maybe that was the case.  The nurse called me back after having speaking to the doctor.  The doctor agree with the nurse that it was not the vaccine that caused the vomiting, but that the child had something viral.  My daughter had not or was not sick at all.  She did not have any kind of symptoms what so ever.  Personally, being an experienced mom of 4, I believe the vaccine had an adverse reaction on my daughter.
patients had been given the only the liquid component of the Pentacel vaccine with no AE; Initial information received on 01-Oct-2020 regarding an unsolicited valid non-serious case from a other health professional.   This case involves a 6-month-old male patient who was given 0.5ml of the liquid component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot U6629AA and expiration date:02-May-2021) via unknown route in the left thigh for prophylactic vaccination on 28-Sep-2020 (PT: product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included HEPATITIS B VACCINE; PNEUMOCOCCAL VACCINE 13V ; ROTAVIRUS VACCINE and INFLUENZA VACCINE for prophylactic vaccination.  It was an actual medication error case due to inappropriate reconstitution technique (same day latency), as the only the liquid component of the Pentacel vaccine was given and not the powder part.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recv vax 14MAy98 & seen 25MAY98 w/in 24hr bright red maculopapular rash-confluent on face, less elsewhere;
Headache, Myalgia, NauseaVomiting, pain,itchy at injection site, loss of taste, chills Narrative:
sleep walking; Parkinson's Disease; Internal tremors; vivid dreams; Ache; This case was reported by a pharmacist via call center representative and described the occurrence of parkinson's disease in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 592DX, expiry date 6th December 2021) for prophylaxis.   Co-suspect products included influenza virus vaccine inactivated (Fluzone Hd) for prophylaxis.   On 17th October 2019, the patient received the 1st dose of Shingrix and Fluzone Hd at an unknown dose and frequency. On 18th October 2019, 1 days after receiving Shingrix, the patient experienced pain. On 20th October 2019, the patient experienced parkinson's disease (serious criteria GSK medically significant), shaking inside and vivid dreams. On an unknown date, the patient experienced sleep walking. On an unknown date, the outcome of the parkinson's disease, pain, shaking inside, vivid dreams and sleep walking were unknown.   The reporter considered the parkinson's disease, shaking inside and vivid dreams to be related to Shingrix. It was unknown if the reporter considered the pain and sleep walking to be related to Shingrix.  Additional information was provided as follows: The first dose of Shingrix was received and on the next day the patient complained of achiness.  On 20th October 2019 the following Sunday, patient experienced vivid dreams ,then went on to develop interior(Internal) like tremors. The patient was diagnosed with Parkinson's disease. The patient experienced 2 episodes of sleep walking, unsure if still experiencing. The reporter consented to follow up.
Congestion in my throat with postnasal drip for about 4-5 days and stayed home. After being clear for 6 days it came back, and I decided to seek care. 4/6/2022 At Urgent care I had COVID-19, strep, and Flu, all came back negative. The doctor suggested to drink more fluids and take anti-histamine. I just went home and got more rest.  After about a day I felt right as rain and up to today (4/21/2021) feel that I have recovered.
Felt lightheaded 1-2 hours after injection, then arm was sore for 1-2 days...on the 11th day after receiving, the injection site became sore again and then experienced fairly severe muscular pain down the entirety of the left arm. On 2/28, noticed the first skin lesion on my left arm..it looked like shingles..muscular pain increased and now have 8 similar looking lesions...went to doctor and he said that since I had no pain  to the touch of my skin, it likely was not shingles but a delayed reaction to the vaccination.
After 1st dose, she noticed her fingers were tingling on and off.; When I was driving car, my hands went numb.; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (After 1st dose, she noticed her fingers were tingling on and off.) and HYPOAESTHESIA (When I was driving car, my hands went numb.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (After 1st dose, she noticed her fingers were tingling on and off.) and HYPOAESTHESIA (When I was driving car, my hands went numb.). At the time of the report, PARAESTHESIA (After 1st dose, she noticed her fingers were tingling on and off.) and HYPOAESTHESIA (When I was driving car, my hands went numb.) outcome was unknown.        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.   Treatment to the events given as hot bath.   This case was linked to MOD-2021-386892, MOD-2021-386893 (Patient Link).
1 of 2 adult pts who exp a localized reaction following immun; pt devel erythema from the deltoid to the elbow; required ER/MD visit; last immun was given in 1986 or 1987;
Woke up Wednesday morning and a large square red patch on right arm. When I touch it, the site is warm to the touch. Also, arm is sore. Pfizer shots
tested positive for COVID 19 with symptoms/tested positive for COVID 19/headache and fever; This is a spontaneous report from a contactable healthcare professional (reported for herself; patient). This 52-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 10Mar2021 at 08:30 am (age at vaccination was 52 years; Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing. Patient had no allergies to medications, food, or other products. The patient had no other concomitant medications within two weeks. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID prior to vaccination. Patient reported that some days after receiving the vaccine she presented with headache and fever. Start date of adverse events was provided as 17Mar2021 at 4:00 PM. She went to the doctor office/clinic on 21Mar2021 and tested positive for COVID 19 on 22Mar2021 with nasal swab COVID test. Events were treated with ibuprofen and Vitamin C. Her doctor recommended she not receive the second dose for now, which was scheduled on 31Mar2021, and she should wait at least 2 months. Patient was recovering from headache, fever, and tested positive for COVID.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
At the injection site, a 7x10 cm area of erythema with minimal swelling. No systemic symptoms.  Treated with oral steroids. Parent to re-check with us if not improving.
Red spots, 5-10mm, in diaper area 25 hrs post/vax. Within a few hrs, it had spread over entire body. Mom took child to Dr, on arrival, child had fever 101, given Motrin, screaming, pain in joints, covered w/hives, tx'd w/Benadryl, is better
Pt presented to ED with c/o SOB x1 week and c/o CP with deep breath that radiates to Left side and shoulder.  Febrile Tmax 101.9, HR 110's and RR 30's.  Pt is fully vaccinated with booster.  Had exposure to coworkers who tested positive for Covid19.  Pt now Covid +.  Given po/IV steroids and abx.
This spontaneous report was received from a pharmacist via field representative refers to a male patient of unknown age. Patient's pertinent medical history and drug reactions/allergies were unspecified. On an unspecified date in 2015 (reported as earlier this week) the patient received ZOSTAVAX, .65 ml (therapy route, lot # and expiry date unspecified). Concomitant medications were unspecified. Reporting pharmacist stated that the patient experienced an adverse reaction to ZOSTAVAX earlier this week and further explained the adverse reaction as a total body rash. There were no other symptoms reported. Patient sought medical attention of an unspecified type. No treatment was given for the adverse event. Lab diagnostic studies were unspecified. Outcome of the event, rash generalized was reported as recovering. Causality assessment was not provided. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly storage VAQTA, lot number M033611, expiration date 02-MAR-2018, lot number M027879, expiration date 24-JAN-2018, lot number M047658, expiration date 28-OCT-2017, (strength, dose, dose number, route and  anatomical location were not reported), for prophylaxis. The temperature excursion was reported below 32 Fahrenheit degrees (0 Celsius degrees), time frame of 25 hours 5 minutes. The vaccines did not experience any previous temperature excursion. Digital data logger was involved. No product quality complain was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA007383: US-009507513-1702USA007382: US-009507513-1702USA002897: US-009507513-1702USA007381:
Narrative:  At Mental Health visit, patient showed picture of lip and facial swelling that occurred 12 hours post-booster to nurse. No further details given.