chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4 1/2 hrs had elapsed since APAP administered because pt was asleep; when pt awoke APAP was given & shortly p/began to shake as if had a chill & lips turned purple; pt was checked by ER MD & told had not had a seizure but poss DTP rxn;
Gets lightheaded when she gets up; Can't get warm; Achy all night/severe body aches; Severe chills; Temperature from 99.8 F - 100.8 F; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Gets lightheaded when she gets up), FEELING COLD (Can't get warm), MYALGIA (Achy all night/severe body aches), CHILLS (Severe chills) and PYREXIA (Temperature from 99.8 F - 100.8 F) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036821a) for COVID-19 vaccination.     The patient's past medical history included Chills, Fever and Lightheadedness. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Gets lightheaded when she gets up), FEELING COLD (Can't get warm), MYALGIA (Achy all night/severe body aches), CHILLS (Severe chills) and PYREXIA (Temperature from 99.8 F - 100.8 F). At the time of the report, DIZZINESS (Gets lightheaded when she gets up), FEELING COLD (Can't get warm), MYALGIA (Achy all night/severe body aches), CHILLS (Severe chills) and PYREXIA (Temperature from 99.8 F - 100.8 F) outcome was unknown.            Treatment details were not provided.   This case was linked to MOD-2021-095582 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No specific follow-up information recorded.
Covid-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19 positive) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in 2022. Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (Dose 1, Lot number: 213021A, administered in right arm) on 22-Mar-2021, Janssen COVID-19 Vaccine (Dose 2 (First booster) and administered in right arm) in November 2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE and Janssen COVID-19 Vaccine. Concurrent medical conditions included COPD (Late Stage 3 of COPD) and Cancer (On his 5th year of remission on one cancer).    On 06-Dec-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Jun-2023, the patient experienced COVID-19 (Covid-19 positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) on 27-Jun-2023 for COVID-19, at a dose of 3 dosage form twice a day. At the time of the report, COVID-19 (Covid-19 positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jun-2023, SARS-CoV-2 test: Positive.         No concomitant drug information was provided.  It was reported that the patient had a lot of problems that had been going on for years. Patient called the doctor because he knew he felt like he did when first got sick before. He called his primary physician right away. He did home test kits. Patient was prescribed Paxlovid to take along with other medications, since he tested positive for Covid. He was also prescribed Dexamethasone and Doxycycline Mono 100mg. None of these were on the list one had to make sure was not also taking.  He clarified further he was calling because regular pharmacy did not have Paxlovid. He then had to call another one in town to get it. The first day he had it, but had no mood to read the stuff that came with it. He just started dosing. A day before reporting, patient was looking at the packaging. Everything was right on pills. The numbers that should be on them were on them. On the outside of box it had a lot number. However, the expiration date was listed as Apr 2023 which had already passed. He saw the expiration date and it was now the end of June almost July. The patient however, was not sick from it and he was on his third day of it.
Information has been received from a registered nurse concerning a female patient with no allergies, who on 06-MAR-2008 was vaccinated subcutaneously with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (Lot # 655291/0985F). On 06-MAR-2008 the patient developed pain at the injection site and flu like symptoms including vomiting. The patient went to the emergency room and was released, but it was not known if the patient received any treatment. No diagnostic laboratory studies were performed. At the time of this report, the patient was recovering. No product quality complaint was involved. This is one of three reports from the same source. Additional information has been requested.
Hives/rash over several parts of body / "UrticarialHypersensitivity Reaction"; This is a spontaneous report from a contactable nurse. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK9231) via an unspecified route of administration in the left arm on 09Jan2021 at 19:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 30Jan2021 at 16:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. Concomitant medications included dietary supplements (MANUFACTURER UNKNOWN), taken for an unspecified indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Jan2021, after the first vaccine, the patient developed areas of hives/ rash over several parts of body, not immediately but days later and became severe after the second vaccine dose. The event resulted in a visit to the doctors or other healthcare professional office/clinic visit. The patient had seen a dermatologist and an allergist and had extensive allergy testing done. On an unknown date, the patient underwent biopsy of the rash and the result was urticarial hypersensitivity reaction. Therapeutic measures were taken as a result of the event and included treatment with prednisone oral, topical steroids and antihistamines. The clinical outcome of the event hives/ rash over several parts of body was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sore arm, headache, fever. Chills, nasal ear pain, nauseated
Pt reported significant swelling in lymph nodes in L clavicle and L armpit 2 days after injection. Still some soreness at injection site and some swelling in clavicle but overall swelling has decreased.
Tried mylicon, maalox w/ orajel, tylenol, motrin. Random bursts of screaming for around 30 seconds every couple of minutes. Crying episodes X 2.5 days now, eating well, good urine output, playful/smiling at times, no fever.
Fever, chills, muscle aches, nausea, some soreness at site of injection. Started about 7 hours after administration.
Patient reported that on 3.6.18 her whole upper arm became very red and she felt achy, tired and slightly feverish. By March 10th her arm was itchy and covered in a bad rash she treated with hydrocortisone. Patient was encouraged via telephone on 3.12.19 to make an appointment to be checked by her provider, but declined, stating now her arm just has a red ring around the area where the injection was given. Injection given by CMA at Health Center. Patient agreeable to seeking care tomorrow if the problem is not resolved.
Since getting the Pfizer vaccines, I have developed a rare Desmoid tumor behind my knee and had a bout of Costocondritis, which SHOULD be recorded somewhere.  I will likely never know if these weird things are the result of having gotten the COVID vaccines or not...
baby was administered the Pediarix,Hib,pcv and Rotavirus;before and after the vaccine administration baby appeared in good health,stable;no adverse effect observed in clinic or home;the next morning,after being fed and put to sleep on his tummy, baby was found unconscious, face down in crib and expired in E.R.  7/3/07 Received vax records which confirm RO lot & dose # as reported.  11/27/07 Reviewed autopsy report which states COD as undetermined & manner of death undetermined.  Diagnoses included: sudden death of 2 mo old baby boy sleeping prone in bassinet on blanket found face down with anterior fixed lividity on abdomen & surrounding nose & mouth; atrial septal defect, secundum type; 6 fingers on each hand.
I experienced very bad chills and  was extremely passed out after feeling dizzy and had fever. Was taken to the ER by my husband.
Found him unconscious; Seizure; severe migraine headache for 4 days; he had a rather severe reaction; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Found him unconscious) and SEIZURE (Seizure) in a 30-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.     The patient's past medical history included Craniectomy in 2020. Concurrent medical conditions included Traumatic brain injury since 2020 and Seizures. Concomitant products included LEVETIRACETAM (KEPPRA XR) and LAMOTRIGINE (LAMOTRIGINE A) for Seizure, FLECAINIDE, METOPROLOL, DEXAMFETAMINE SULFATE (DEXEDRINE), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and TIZANIDINE HYDROCHLORIDE (ZANAFLEX) for an unknown indication.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced LOSS OF CONSCIOUSNESS (Found him unconscious) (seriousness criterion hospitalization) and SEIZURE (Seizure) (seriousness criterion hospitalization). On an unknown date, the patient experienced MIGRAINE (severe migraine headache for 4 days) and VACCINATION COMPLICATION (he had a rather severe reaction). The patient was hospitalized from 26-Oct-2021 to 29-Oct-2021 due to LOSS OF CONSCIOUSNESS and SEIZURE. At the time of the report, LOSS OF CONSCIOUSNESS (Found him unconscious), SEIZURE (Seizure) and VACCINATION COMPLICATION (he had a rather severe reaction) outcome was unknown and MIGRAINE (severe migraine headache for 4 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that Protonix (stopped in the hospital) , and Zanaflex (stopped in the hospital) prior to vaccination. No treatment medications were provided.  On unknown date the patient experienced lingering bad headache. On 26 Oct 2021, the patient experienced at day 11, he had a non-convulsive seizure.  Company comment: This case concerns a 30 year-old male patient with history of craniocerebral injury and seizure, who experienced the unexpected serious events of Loss of consciousness and Seizure. The events occurred 12 days after the first dose of mRNA-1273 vaccine. The patient's history of seizure and craniocerebral injury remain as confounders for the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Follow-up received added reporter, patient, drug and event information.; Sender's Comments: This case concerns a 30 year-old male patient with history of craniocerebral injury and seizure, who experienced the unexpected serious events of Loss of consciousness and Seizure. The events occurred 12 days after the first dose of mRNA-1273 vaccine. The patient's history of seizure and craniocerebral injury remain as confounders for the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Slight cold; Some buggers; feeling not too bad nor temperature in the body; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Slight cold), VACCINATION COMPLICATION (Some buggers) and FEELING ABNORMAL (feeling not too bad nor temperature in the body) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced NASOPHARYNGITIS (Slight cold), VACCINATION COMPLICATION (Some buggers) and FEELING ABNORMAL (feeling not too bad nor temperature in the body). At the time of the report, NASOPHARYNGITIS (Slight cold), VACCINATION COMPLICATION (Some buggers) and FEELING ABNORMAL (feeling not too bad nor temperature in the body) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow up received. Outcome of events updated as resolved.
patients received day 0 dose of Imovax Rabies but  did not come back yet for day 3  dose/ No  AE; Initial information was received on 31-Mar-2020 regarding an unsolicited valid non-serious case from a nurse  This case involves family of four patients of unknown demographics who were vaccinated with first dose (Day 0) of RABIES (HDC) VACCINE [IMOVAX RABIES] (lot number and expiry date were not reported) via unknown route in an unknown administration site for post exposure immunisation on but the patients did not come back yet for next (Day 3) dose (incomplete course of vaccination)  Medical history, medical treatment(s), past vaccination(s) and family history were not provided.  It was an actual medication error case due to incomplete course of vaccination as the family did not come back yet for next (Day 3) dose.  At a time of reporting no adverse event reported.  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.  There will be no information available on the batch number for this case.
Saturday and Sunday- Pain in arm. Monday- Red, swollen at injection site, unable to move arm in full range of motion, pain under arm and halfway down side (She said, "My armpit feels swollen.")
"walking strange"; feeling dizzy; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE ("walking strange") and DIZZINESS (feeling dizzy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-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 GAIT DISTURBANCE ("walking strange") and DIZZINESS (feeling dizzy). At the time of the report, GAIT DISTURBANCE ("walking strange") and DIZZINESS (feeling dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medications were provided. No treatment medication was reported.  "walking strange" and feeling dizzy were recurred on 06Apr2021 and they were thinking that might be due to patient's sugar level. The patient was scheduled to get the 2nd dose today (07Apr2021) but they want to have patient checked first.
Awoken by muscle spasm in both calves. Severe pain and discomfort. Waned yesterday morning to about a 2/10.  Last evening severe pain and spasms in both arms and both calves.  This morning the same. Had to call out of work (a career firefighter/paramedic) due to severe discomfort. Losing 24 hours of work.   Have been taking ibuprofen and using percussion theragun massager with little to no relief.
Patient reports her right arm as red, very swollen, and very painful (describing as too painful to touch her arm). She said it is warm to touch.
No symptoms reported; a patient received an expired dose of PROQUAD; This spontaneous report was received from a medical assistant, referring to a 9-year-old female patient. The patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies were not reported.  On 09-JAN-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHa) injections, administered subcutaneously as prophylaxis (dose number and anatomical location were not reported; lot number R014353 has been verified to be valid, expiration date reported and validated as 18-NOV-2019) (expired product administered). Concomitantly, an sterile diluent (MERCK STERILE DILUENT) was used with the vaccine (lot number S002623 and expiration date reported as 28-OCT-2021).   It was reported that the measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was stored properly. No symptoms reported.
Pateint received under diluted dose of covid 5-11 Pfizer vaccine. No adverse event reported.
Roughly two hours after injection I began to feel a severe headache. All traditional methods to combat a headache provided temporary relief at best. after 36 hours the headache subsided. In addition to this I had minor stomach aches, and tiredness.
No PQC or additional AEs reported.; vaccine administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.   On 11-MAR-2021, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength was not provided; lot# was 1691300 and expiration date was 24-NOV-2021) which was involved in a temperature excursion, 2 milliliter orally for prophylaxis.  The administered dose was involved in a temperature excursion at 11.7 degree Celsius for 75 minutes. There was no previous temperature excursion. It was detected by a date logger. No additional adverse events (AEs) was reported.
total body rash fever - 103.4 ax fever lasted 3 days (fever treated w/APAP); also exp 24 hrs of vomiting; mom contacted MD;
Patient was given 5-11 year old Pfizer vaccine instead of Pediatric Moderna 6 month - 5 years
Received first dose of the Pfizer COVID vaccine on 1/8/2021.   On 1/16/2021 developed body aches and headache.  Tested positive for COVID-19.
Information has been received from a 37 year old female with no allergy and medical history who on 18-AUG-2008 was vaccinated with a first dose of GARDASIL.  On 22-OCT-2008, the patient was vaccinated with a second dose of GARDASIL.  Concomitant therapy included oral OCELLA.  On 08-NOV-2008 the patient experienced severe itching all over her body, mainly on her chest, back, stomach and all pressure points.  On 13-NOV-2008 the patient was put on oral steroids.  On 25-NOv-2008, the patient recovered from the events.  The steroids did not work completely and received a second oral steroid which did help the itching.  Additional information has been requested.
deathly ill; Initial information regarding this unsolicited valid non-serious social media case received from a consumer  and transmitted to Sanofi on 15-Jan-2021.  The case involved a patient who was deathly ill (illness), while the patient received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious deathly ill (illness), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
On 03/23/07, ten days after receiving the first dose of varicella vaccine the patient developed a raised reddened area on her left arm approximately the size of 2 quarters.  The area was itchy. On 03/27/07 patient describes "flu-like" symptoms of nausea, headache and malaise.  Patient denies fever.
In other box, but developed relapse of Graves Disease and Thyroid Eye Disease shortly after Booster. 9/29/21 with symptoms noticeable and blood labs by mid-November. Also had flu shot in  mid-Oct.
A non-serious spontaneous report of wheezing has been received from a health professional concerning a ten-year-old female, subsequent to FLUMIST. The patient's past medical history includes wheezing, but hadn't for four to five years. Concomitant medications were not reported. The patient received FLUMIST in the first week of Aug-2011. The patient had a wheezing episode a few hours after FLUMIST administration. The child was given albuterol treatment and wheezing was cleared. There were no further symptoms. The outcome of the event of wheezing was resolved in Aug-2011. The reporter assessed the event of wheezing as not related to FLUMIST.
Body aches; Fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Body aches) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Body aches) and PYREXIA (Fever). At the time of the report, PAIN (Body aches) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not reported.   Reporter did not allow further contact
shingles; This is a spontaneous report from a contactable consumer. This consumer reported similar event for mother in law and 3 other people. This report is for 1 of those 3 people.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration, on an unspecified date as dose number unknown, single for Covid-19 immunisation. Patient's medical history and concomitant medications were not reported. After vaccination, the patient experienced shingles on an unspecified date. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021513947 Same reporter, product, event/ different patient;US-PFIZER INC-2021513968 Same reporter, product, event/ different patient