chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shaking and trembling; Headache; Chills; Pains; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Chills), PAIN (Pains) and TREMOR (Shaking and trembling) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included FUROSEMIDE, SPIRONOLACTONE, CARVEDILOL, IRBESARTAN, ATORVASTATIN, IRON (IRON COMPLEX [IRON]) and OMEPRAZOLE for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced CHILLS (Chills) and PAIN (Pains). On 26-Feb-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced TREMOR (Shaking and trembling). At the time of the report, HEADACHE (Headache), CHILLS (Chills), PAIN (Pains) and TREMOR (Shaking and trembling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.
This spontaneous report was received from a pharmacist referring to unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. The reporter stated that her coworkers re-administer PNEUMOVAX 23 to the  patients every 5 years regardless of how many previous doses of PNEUMOVAX 23 those patients have received or at what ages those previous doses were received. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA005477: US-009507513-1612USA005475: US-009507513-1612USA005476: US-009507513-1612USA005473: US-009507513-1612USA004758.
positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) of an unspecified age reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 15Jan2021, the patient tested positive for a COVID-19 test. The patient was put in isolation. She should receive her second dose on 19Jan2021, but she had to cancel her second shot since she was tested positive and she couldn't go. She called in because she wanted to reschedule her second shot of the vaccine. Local authorities can't give her second dose of vaccine until mid of February. She's trying to find out if it's okay. At the time of the report, the outcome of the events was unknown.  The information on the lot/batch number has been requested.
per foster mom pt c/o pain in lt arm; awoke Wed AM w/erythema from point of shoulder to elbow, silver dollar size induration @ inject site; temp was not taken but states felt pt may have fever for 3 days;
Information has been received from a healthcare worker indicating that improperly stored GARDASIL (Lot # not reported) might have been administered. No adverse event reported. Follow-up information was received from the healthcare worker indicating that on unknown dates an unspecified number of patients received GARDASIL (dose, route and lot # not reported) which had been improperly stored. No symptoms were reported. Follow up information has been received from a administrative assistant, concerning about one of three male patient (age not reported) who on an unknown date was vaccinated with a dose of GARDASIL (dose, route not reported), (Lot # 669796/0840AA) which had been improperly stored. The vaccine was re-administered to the patient (on an unknown date), dose, route and Lot# not reported. The administrative assistant stated that there had been no adverse events reported at the time. This is one of several reports from the same source. Additional information is not expected.
I started getting rashes 2 weeks after the first vaccine, very itchy bumps on my leg then my side; Shingles; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 26Mar2021 13:15 (Batch/Lot Number: ER8727) (at the age of 55 years old) as 1st dose, single for COVID-19 immunisation. The patient is not pregnant at the time of vaccination. Medical history included healthy (as reported), allergic to latex, little overweight, asthma and acid reflux. Concomitant medications included levothyroxine sodium (LEVOXYL); famotidine (PEPCID AC); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]); and cyclobenzaprine hydrochloride (CYCLOBENZAPRIN), all taken for an unspecified indication, start and stop date were not reported. The patient previously took Vicodin and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient started getting rashes on 08Apr2021 (also reported as2  weeks after the first vaccine), very itchy bumps on leg then side. The patient thought it was shingles and contacted the doctor. They went away with Benadryl and time. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included covid test type post vaccination= Nasal Swab: negative on 19Apr2021. The outcome of the events was recovered in Apr2021.
The pt developed approximately 4 inch round area 24 hours after DTaP administration. There were small light red raised areas in this area. It was present for five days with no problems otherwise.
Information has been received from a medical assistant referring to a 3 month old male patient. No relevant medical history or concurrent conditions were reported. On 10-JUN-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
increased blood pressure and never had it before; This is a spontaneous report from a contactable physician. A 101-year-old female patient received bnt162b2 (BNT162B2, Solution for injection) via unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The caller's cousin got the vaccine and after that she developed increased blood pressure and never had it before. Outcome of the event was unknown.  Follow-up attempts are needed . Further information has been requested.
local reaction of swelling lt deltoid muscle; exp rash other than @ inject site; seen by personal MD who prescribed medication; mom states rash was gone in 1 day, however, the swelling persisted for @ least 1 wk;
Patient became slow to respond, somewhat altered and lethargic.  She was immediately brought to the ED for evaluation.  A stroke was ruled out however the patient was admitted for further evaluation and workup.
RIGHT SIDE LYMPH NODES ALL SWOLLEN UNDER ARMPIT AND IN THE BREAST
sore arm where vaccine was administered; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 37-years-old non-pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL3247), via an unspecified route of administration, administered in Arm Left on 23Feb2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no COVID prior to vaccination and was not tested for COVID. On 23Feb2021, the patient experienced sore arm where vaccine was administered. The patient did not receive any treatment for adverse event. The event outcome was recovered on an unspecified date.   Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Severe migraine morning after vaccine lasting over 4 days. Patient went to Emergency room for relief.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not received any other medication in 2 weeks. The patient was treated with Paxlivid from 23May2022 to 27May2022 for COVID-19. The vaccine lot number was unknown as unable to locate or read the details. The patient did not had any known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
5 - 10 minutes post vax, pt developed an urticarial rash.  The rash persisted and lasted approximately 2 - 3 hours each occurrence.  Atarax is being administered every 4 - 6 hours.
Beginning 6/20/2021 at 7:00am: low fever for 2 days, body aches for 4 days, stomach pain 4 days, serious headache for 6 days. Still have headache from time to time. heavy period for 12 days. depression still on 7/12/2021.
Pt took her 14 mo booster and about 10 days later I found her unconscious in her bed. Her eyes were set and we rushed her to the hospital. After test the doctor couldn't find anything until she broke out in rash over stomach. She had a reaction to the measles part of vaccine. She don't know they were done was having convulsions. She was on phenobarbitol for about a year. Lay in her bed and jerked when sleeping still does sometimes and also prefers sleeping in a chair. She can't get along with anyone well enough to hold a job and I had to take her out of school because she couldn't get along with her teachers. She has had a serious accident because she was having convulsions with high fever (she always does). She has been in hosp several times because of convulsions and stayed in a seizure for a long time, possibly over an hr. She has to sleep a lot and tires very quickly.
vaccine has temperature excursions below32F was administered to a patient, no advesre event; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown demographic patient who was vaccinated with a dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number, Exp. Date, dose, route and site of administration not reported) on an unknown date.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to incorrect product storage.  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 and Module VI of the 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.  Information on the batch number was requested.
This medically confirmed report (initial receipt 16-May-2013) concerns a 51-year-old female patient who had a relevant medical history of neck problems from a motor vehicle accident. She had no history of hypersensitivity. In 1990 she had hepatitis B injections; two years ago she received the tetanus/diphtheria shot and has not had the pneumococcal injection. She received the flu shot every year. In mid Dec-2012 the patient received influenza vaccine (manufacturer and batch number not specified) in the deltoid of the left arm and ZOSTAVAX (batch number not specified) subcutaneously in the right posterior aspect part of the arm. She received both vaccinations at the same time. Within a few days of receiving the vaccinations the patient experienced a pretty big response. She developed a large red bump that was the size of an egg, swelling, itching and a headache. Three weeks later in Jan-2013 she developed scapular pain, numbness of the right hand and excruciating pain explained as numbness in the thumb, index finger and middle finger of the right hand. She saw an orthopaedic doctor who ordered an MRI (magnetic resonance imaging). The results were not reported. She also saw a neurosurgeon. Reporters comment: The patient stated that she told her neurosurgeon that she received ZOSTAVAX and where it was injected who said it could have caused irritation.
general fever after the first dose; little headache after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (general fever after the first dose) and HEADACHE (little headache after the first dose) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (general fever after the first dose) and HEADACHE (little headache after the first dose). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (general fever after the first dose) and HEADACHE (little headache after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Patient was drinking water for fever.   This case was linked to MOD-2021-300062 (Patient Link).
She got both vaccines, she was sick when she got home with fever, headache, could not eat she was so sick.  Towards Monday evening she continued to stay sick.  On Wednesday and Thursday she noticed a rash on her body and has been increasing to now she is covered all over her body with a rash.  She did not call her doctor for this rash.  She has not taken anything for the rash.  She is over the fever and loss of appetite, just has the rash  now.
injection site was red, raised, hard, and itching; injection site was red, raised, hard, and itching; injection site was red, raised, hard, and itching; fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (injection site was red, raised, hard, and itching), VACCINATION SITE PRURITUS (injection site was red, raised, hard, and itching), VACCINATION SITE ERYTHEMA (injection site was red, raised, hard, and itching) and PYREXIA (fever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 13-Jan-2021, the patient experienced PYREXIA (fever). On 20-Jan-2021, the patient experienced VACCINATION SITE INDURATION (injection site was red, raised, hard, and itching), VACCINATION SITE PRURITUS (injection site was red, raised, hard, and itching) and VACCINATION SITE ERYTHEMA (injection site was red, raised, hard, and itching). On 15-Jan-2021, PYREXIA (fever) had resolved. At the time of the report, VACCINATION SITE INDURATION (injection site was red, raised, hard, and itching), VACCINATION SITE PRURITUS (injection site was red, raised, hard, and itching) and VACCINATION SITE ERYTHEMA (injection site was red, raised, hard, and itching) 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.   Concomitant product use was unknown by the reporter.   Treatment information was not provided/unknown.
Migraines, up to 4 per week . High blood pressure when none existed prior. Blood pressure rising to stroke levels, then on other days lowering to 70/40 with fainting spells, at least once a week triggering Vasco-vagal syncope  events.
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe
Small cluster of hives appeared on back of neck just around 24 hours after first dose of vaccine. It has been six days since getting the vaccine and still no signs of them disappearing.  Followed the guideline of taking 50mg of diphenhydramine as suggested with minimal success in getting the hives to go down completely.  They will subside slightly sometimes but not at all entirely and are currently still present. There is occasional itchiness which comes and goes as well as  a slight itchy burning sensation in the right hand seemingly random at times.  A small hive also developed on the right hand that does not originate from where the itch on the hand comes from.
About 7 hours after the shot is when things got really intense, but before that I had some aching and headaches. I got really bad chills and felt like I couldn?t get warm. Everything hurt, all the way down to my toes. My arm soreness is still lingering and Last night I still had issues with temperature regulation? feeling cold and then having night sweats.
then experienced flu like symptoms the following day around 10:00 am; Sore shoulder about 2 hours after shot; Exhausted; Weak; Chills; Headache; Feverish; Joint aches; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0162) via an unspecified route of administration in the left arm on 16Apr2021 at 14:15 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the left arm on 26Mar2021 at 14:15 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. On 16Apr2021 about 2 hours after the shot, the patient experienced sore shoulder. On 17Apr2021 the following day around 10:00, the patient experienced flu like symptoms. On an unknown date in Apr2021, the patient experienced exhausted, weak, joint aches, chills, headache and feverish. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events exhausted, weak, chills, headache, feverish, sore shoulder, joint aches and flu like symptoms were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Vertigo.  Treated with Meclizine and decongestant.  Then had vestibular therapy, three sessions.  The vertigo has resolved.
Pfizer Vaccine lot #FE3594 was affected due to out of temperature range. No adverse reactions from patients.  7 patient's affected.
Pitting Edema in both legs; sharp shooting pains in chest occasionally; Trouble catching my breath when walking 20-30 feet.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Sep2022 at 15:00 as dose 3 (booster), single (Lot number: GJG739), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cough" (unspecified if ongoing); "Asthma with Exercise" (unspecified if ongoing). Concomitant medication(s) included: FLULAVAL QUADRIVALENT, on 30Aug2022 as dose 1, 0.5 ml single; NORTRIPTYLINE; AMBIEN; TOPAMAX; ZOLOFT; BUTRANS. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin". Vaccination history included: pfizer (Dose 2, Batch/Lot No: EL1203, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 26Jan2021, when the patient was 32-year-old, for Covid-19 Immunization, reaction(s): "Covid-19"; pfizer (Dose 1, Batch/Lot No: EL1284, Location of injection: Arm Left, Vaccine Administration Time: 07:30 AM), administration date: 05Jan2021, when the patient was 32-year-old, for Covid-19 Immunization, reaction(s): "Covid-19". The following information was reported: OEDEMA PERIPHERAL (non-serious) with onset 04Oct2022 at 08:00, outcome "not recovered", described as "Pitting Edema in both legs"; DYSPNOEA EXERTIONAL (non-serious) with onset 04Oct2022 at 08:00, outcome "not recovered", described as "Trouble catching my breath when walking 20-30 feet."; CHEST PAIN (non-serious) with onset 04Oct2022 at 08:00, outcome "not recovered", described as "sharp shooting pains in chest occasionally". Therapeutic measures were not taken as a result of oedema peripheral, chest pain, dyspnoea exertional.
I started with a fever and a headache about 3 hours after receiving the vaccine.  I took Tylenol and felt better.  About 10 am that evening I had chills, I jumped in the shower to warm up my body which helped and I went to bed.   Wednesday about mid day I became quite nauseated, dizziness and just did not feel well.  I took benedryl that evening and went to bed.  Thursday around mid- day again I continued to have nausea and dizziness, then I also started having chest tightness, I used my albuterol inhaler which is new to me for allergy induced asthma, which helped.  Overnight Thursday into Friday I woke up in the night and had sweat through my clothes.   I had the same symptoms carry on into Friday.  Saturday I was beginning to feel better until mid afternoon I had a different chest discomfort and nausea and I reported to the emergency room they ruled out a cardiac event, gave me 2 baby aspirin and zofran and sent me home.  Sunday I woke up with a terrible migraine I treated with alternating tylenol and ibuprofen for about 24 hours.  Monday- Tuesday- Wednesday I just felt worn out, fatigued over all not well.  Thursday I finally started feeling better and contiue dto feel better.
Urticaria. I got rash that was very itchy almost everyday starting from 04/21. I need to take certirizine for a relief while it comes back immediately after stoping the medcine.
12 year old male patient came in for a Well Child Check (physical) and he received an adult dose of the Hepatitis A vaccine. On 5/25/18 I finally made contact with mom and informed her of the dose error and reassured her vaccines are safe and more than likely, no adverse reaction. She said her son never complained about it.