chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Calf discomfort; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Calf discomfort) in a  patient of an unknown age and gender 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 LIMB DISCOMFORT (Calf discomfort). At the time of the report, LIMB DISCOMFORT (Calf discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was reported  No treatment medication information was reported   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Additional information included patient initials
About 10-15 hours after injection - Came down with headache, fever, body aches, fatigue, and night sweats.  Recovered fully 24 hours after injection.  May 5th, 2021 ~7:30 am (4 days post-vaccination) I stood up from a seated position and then collapsed moments later and had, what my brother described as, a seizure which was followed by confusion, nausea, and fatigue.
DTaP administered 04/26/2003 and patient exposed to chickenpox a week before DTaP administered.  Patient developed chickenpox rash with patients right buttock having large papular rash were shot administered.
Gas, Diarrhea-Mucus (immediate, lasted for 7 seven); Sinus infection, brown mucus, cough up blood, trouble breathing
A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced oxygen level of 86, temperature of 91 degrees, cough, and runny nose. The patient's medical history was not provided. Concomitant product use was not provided. The patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) on 17 Feb 2021 for prophylaxis of COVID-19 infection. On 24 Feb 2021, 8 days after the patient experienced oxygen level of 86, temperature of 91 degrees, cough, and runny nose. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the reported events was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; Sender's Comments: MOD-2021-024256:same reporter, different patient and event.
Vaccine area warm to touch, red and itchy.  lump is size of width of orange.
Red blotchiness around injection site-(doesn't remember which arm) 1/2" in size. Slightly swollen and tender. Lasted approx. 1-2 days. Has had flu vac for approx. 20 yr-never developed rash before.
OUTER SIDE OF RIGHT FOOT AND  3RD AND 5TH DIGIT ARE BLUISH/PURPLE, THEN RED, SWOLLEN AND PAINFUL. NO OTHER EXPLANATION FOUND FOR THIS ISSUE
The pt experienced a fever of 102, headache, dizziness. Went to the ER and pt felt better 3 hours later.
Ran a fever for 2 days strait of around 102. Could not lift even the slightest things. I had slurred speech and I felt drunk. Was too weak to even get out of the bed for 2 days. My lymph nodes were swollen and still are. I still cannot lift my right arm over my head going on day 4.
Severe flu like symptoms (myalgias, fever, chills, fatigue) that developed 24 hours after vaccine was received and lasted for 48 hours.
Dizziness, extreme nausea,  fever (101 degree F), chills, trouble breathing (96 pulse ox), incredibly bad headache on right side.
Patient admitted for respiratory failure related to heart failure.  Has had ongoing shortness of breath over last few months.
My son has had vaccine injuries that I was unaware of because my doctor never told me the signs to look for but after educating myself about the vaccines and the injuries and thinking back I now realize it's because of the vaccines that my son can't talk.
Red, warm, swollen, tender area in left deltoid 1 day after shots.  Placed on antibiotics and antihistamine.
Patient was given 3rd dose of Anthrax Vaccine on 03Feb03.  Was subsequently admitted for HSV encephalitis on 17Feb03. Received treatment and initial rehab.  Currently with encephalopathy (permanence as yet undetermined). Discharge summary states Herpes encephalopathy, renal insufficency, headache.
6 individuals received a 0.3ml dose of undiluted Pfizer Covid-19 vaccine; 6 individuals received a 0.3ml dose of undiluted Pfizer Covid-19 vaccine; chills; shakes; This is a spontaneous report from a non-contactable other health care professional (Nurse). This nurse reported similar events for 5 patients. This is 5th of 5 reports. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 05Feb2021 as DOSE NUMBER UNKNOWN, 0.3ML SINGLE for covid-19 immunisation. Patient did not received other vaccines in 4 weeks. Patient did not had COVID prior vaccination. Patient did not tested COVID post vaccination. The patient medical history and concomitant medications were not reported. It was reported that the 6 individuals received a 0.3ml dose of undiluted pfizer covid-19 vaccine, had chills and shakes at 24 hours on 05Feb2021. No side effects observed/reported at 1 hour post vaccination. No side effects/adverse effects were observed/reported at 48 hours post vaccination. No treatment was received. The patient was recovered from chills and shakes. The outcome of the event 6 individuals received a 0.3ml dose of undiluted pfizer covid-19 vaccine was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information includes: Recoded event "Drug maladministration event" to "Overdose", Removed "At risk" classification.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021161810 same reporter/drug/similar AE with different patient
1158:  Vaccination given 1215:  c/o dizziness, transferred to recliner.  Passed out in recliner, airway protected. RR 12 1220:  able to arouse; feels dizzy 1222: BP:  127/58.  HR 62.  SpO2% 97.      Itchy, can barely speak, difficult to arouse.  Epinephrine 0.3 mg IM in Right quad.   1225: BP:  126/58.  HR 60.  SpO2 100 %.     no signs of angioedema: breathing without difficulty; speech more clear; follows commands.  Drank water without signs or symptoms of dysphagia.  States normal HR 80-100. 1235: BP:  123/83.  HR 59.  SpO2 100%.    awake and alert; will continue to observe.  DC at 1300 if stable.  Advised to notify PCP of reaction to determine if 2nd dose advised. 1256:  BP 117/64.  HR 61.  SpO2 98%.  Awake and alert.  Ready to leave in care of husband. 1743:  Called and checked on patient.  Patient doing well.
Gradual onset of night sweats, unexplained, in spite of hormone replacement, starting ~ 6wk after second injection, occurring 2-3x/wk  Symptoms are mild/manageable, but I have heard some others with similar symptoms of hot flashes/night sweats, so thought I would report.
level 9 out of 10 pain in spine making it difficult to walk; 9 out of 10 pain in spine making it difficult to walk lasting 2 weeks; pain in arm; burning in stomach; difficulty swallowing; fever greater than 103,; Swollen lymph node around neck, difficulty swallowing, burning in stomach, fever greater than 103, level 9 out of 10 pain in spine making it difficult to walk lasting 2 weeks and disappeared, pain in; This is a spontaneous report from a contactable other health care professional. A 42-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6198, Expiration date: unknown), via intramuscular, administered in left arm on 03Mar2021 at 10:30 am (at the age of 42-year-old) as single dose for COVID-19 immunization in hospital. The patient medical history includes Post stage 4 breast cancer, autoimmune disease, many surgeries from breast cancer 10 plus years ago, Laminectomy L4-5 >10 years. Allergies to medications, food or other products was reported as yes, but details are not reported. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered in right arm on 10Feb2021 10:30 as single dose for COVID-19 immunisation. Patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medications within 2 weeks of vaccination. On 03Mar2021 16:00, the patient experienced Swollen lymph node around neck, difficulty swallowing, burning in stomach, fever greater than 103, level 9 out of 10 pain in spine making it difficult to walk lasting 2 weeks and disappeared, pain in arm less than 48 hours. Events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was given with Tordol shot and medications for severe spams of spine and back. The events assessed as serious. The patient underwent lab tests and procedures which included body temperature (pyrexia): greater than 103 on 03Mar2021. The outcome of all events was resolved.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events of Gait disturbance, Spinal pain and Pain in arm cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
transient ischemic attack (TIA) mini-stroke; has had a hemorrhage in brain/ fatigue/ in bed with headaches all the time; is allergic to everything; immune system is on overload; food is not agreeing with her; sick all the time; This spontaneous report was received from a consumer, concerning a 20-year-old female patient who was also the girlfriend of the reporter's son. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection as prophylaxis (dosage regimen, route of administration, anatomical location, lot number and expiration date were not reported).  On an unknown date, it was reported that the patient was sick all the time (malaise); had a hemorrhage in brain, was in bed with headaches all the time, had fatigue (cerebral haemorrhage); a transient ischemic attack (TIA) mini-stroke, the patient was allergic to everything (multiple allergies), immune system was on overload (immune system disorder), and food was not agreeing with her (food intolerance).  At the time of the report, the outcome of the events was unknown (also reported as the patient could be getting better or getting worse). The causal relationship between the suspect vaccine and the aforementioned events was not reported.    Upon internal review, the event transient ischaemic attack and cerebral haemorrhage were determined to be medically significant.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA000534:
This is a spontaneous report from a contactable physician via a Pfizer sales representative. This Physician reported a similar event for 2 patients. This is the first of two reports. A patient of unknown age, gender and race/ethnicity received on an unknown date first single dose of TRUMENBA for immunization. Medical history and concomitant medications were not reported. The patient had an extensive rash after receiving meningococcal group b rlp2086. Outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017408672 same reporter, event and drug/different patient.
hurt when the injection was given; Patient was administered with the dose of expired vaccine; Initial information was received on 17-Apr-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 45 years old male patient who experienced hurt when the injection was given (Vaccination site pain), while he received expired vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] (expired product administered).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included JAPANESE ENCEPHALITIS VACCINE INACT (IXIARO) for immunisation.  On 16-Apr-2020, the patient received a 1 mL booster dose of suspect RABIES (HDC) VACCINE (lot N1L132M and expiry date 14-Nov-2019) via unknown route in the right deltoid for prophylactic vaccination  (pre-exposure prophylaxis).  On 16-Apr-2020, the patient developed a non-serious hurt when the injection was given (vaccination site pain) on same day following the administration of RABIES (HDC) VACCINE.  It was also an actual medication error case due to expired vaccine used. The response was injection of an expired or poorly stored vaccine.  No laboratory data was reported.  Final diagnosis was vaccination site pain.   It was not reported if the patient received a corrective treatment.  The outcome was unknown for the event of  vaccination site pain.  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
Wife is feeling a little crummy; This is a spontaneous report from a contactable consumer. A female patient (reporter's wife) of an unspecified age received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) on an unspecified date for COVID-19 immunization. The patient experienced feeling a little crummy on an unspecified date. The outcome of the event was unknown.  Information about the lot and batch number has been requested.
Pt died on 3/6/2021.  Received Vaccine on 2/12/2021.  Unknown cause of death.
ACUTE PULMONARY EMBOLISM 4/19/2023 PNEUMONIA ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/19/2023 PNEUMONIA
DEVELOPED FACIAL AND PERIORAL ERYTHEMA AND HIVES  WITHIN THE INITIAL 15 MIN WAIT TIME. PT WAS GIVEN BENADRYL 12.5MG AND SEE BY PEDIATRICIAN DR. . AFTER AN ADDITIONAL 15 MINUTES RASH SUBSIDED AND PT WAS RELEASED. MOM WAS CALLED AT 515PM AND STATED PT WAS FINE AND RASH WAS GONE
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 11-AUG-2017, the patient was vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported), for prophylaxis. The vaccine was reconstituted with sterile diluent (lot # and expiration date were not reported). The patient received less than a full dose of ZOSTAVAX because during the administration, the vaccine started to leak out of the tip of the syringe. No adverse effects were reported. No Product Quality Complaint (PQC) was involved.
On 12/10/08, pt was given gardasil dose #3 and menactra.  on 12/11/08, while sitting in school, pt had a tonic-clonic seizure and was taken to hospital, admitted, observed 24 hours.  CT scan and blood tests were normal.  EEG abnormal.  MRI and repeat EEG to be done.  Patient has no history of seizure or syncope. 1/29/09-records received for DOS 12/11/08-presented to ED with questionable seizure, tonic-clonic seizure witnessed along with eyes rolling back. Unable to recall event and was disoriented to place and time. PE: slight dizziness.
I had cramps and heavy bleeding during my period after receiving the vaccine. I was also 2 days late getting my period. I have been tracking my period for 13 years now and I have a vary regimented cycle. I am not on birth control of any sort. And I also use a fertility monitor to track my fertility.
symptoms started with nausea and worsened greatly over an hour period. Had projectile vomiting and diarrhea  which last ~4 hours.  later in the evening had dizziness and fainted 2 times. extreme exhaustion lasted approximately 60 hours . symptoms started around 6 hours after injection  dose was given at a mobile site
Pustule-type bumps all over body. Mainly on upper legs and on sides of torso from smallpox vaccination.
Facial numbness left side. aura in lower vision, headache. Numbness left arm.    7 hrs later entire face numb headache continues.  24 hrs later headache still present facial numbness returns and left foot numb.  Noontime 11/13/19 upper lip numbness and headache.
I have a single shingle on my right rib cage.  It is a small red bump with redness around it.  It was itchy and then very painful to touch. It resembles the shingles I had when I was in my 20s.
Hives over entire body, starting on Saturday and getting worse thrus Sunday.  Runny nose, sore throat, hoarseness, headaches, tired, fatigue, general achy
Chills, fever (101+F), body aches started at around 7:30 PM. Sore/aching arm started around 1 PM.
'crackling' noise in my left ear; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS ('crackling' noise in my left ear) in a  patient of an unknown age and gender 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 (While she recovered from Covid-19). Concurrent medical conditions included Ear crackling (the ear crackling continues, intermittently.).   On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS ('crackling' noise in my left ear). At the time of the report, TINNITUS ('crackling' noise in my left ear) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-060759 (Patient Link).
Patient accompanied by father.  Received first does of Pfizer Pediatric Covid Vaccination.  Patient reported headache and almost fell into chair when attempting to sit down in observation area.  She was able to get up in a gurney.  A "Med Stat" was paged overhead through the operator.  She was able to sip water.  Vitals were taken. BP:97/54; HR: 113; Temp: 96.7 degrees F; O2 Sat: 98% at room air, RR: 16.  Lungs clear to auscultation anterior and posterior.   The patient was awake and answering questions.  She was pale.  The MD Stat team arrived and resumed care.  MD resumed care and patient was wheelchaired to pediatric clinic for further observation and evaluation with father accompanying.
This spontaneous report as received from a medical assistant refers to unknown number of patients of unknown age. The reporter reported that an unknown number of doses of VARIVAX (Merck) (lot# unspecified), which underwent temperatures outside the prescribing information (PI) and were supported, had been administered (dose, route unspecified). No adverse effects reported. The outcome of the event was unknown. This is one of two reports from the same reporter. The other report is 1404USA014496. Additional information has been requested.
Patient complaining of pain with movement of right arm. Visualized redness and felt hot to the touch in the area where the varicella vaccine was administered. No swelling noted. Advised patient to put ice on site for 30m with 30m interval breaks to help alleviate the pain/heat/redness. Patient stated understanding.
Pharmacy administered shingrix with the flu / flu like symptoms; flu like symptoms; felt extremely rundown; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a adult patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis and pneumonia shot for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season, Shingrix .5 ml, Tdap Vaccine and pneumonia shot at an unknown dose and frequency. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season and not applicable after receiving Shingrix and Tdap Vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza-like symptoms and fatigue. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza-like symptoms and fatigue were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, influenza-like symptoms and fatigue to be related to Influenza vaccine Quadrivalent unspecified season. It was unknown if the reporter considered the influenza-like symptoms and fatigue to be related to Shingrix and Tdap Vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient received Shingrix with the flu, pneumonia and Tdap all at the same time and patient felt extremely rundown and experienced flu like symptoms for multiple days following. This case was considered as suspected vaccination failure for flu vaccine as details regarding time to onset for target disease and laboratory confirmation were unknown at the time of reporting.  The reporter consented to follow up.
Vaxelis was given instead of quadracel. Extra dose of HIB and HEPB given. Client is okay, no reaction noticed. No symptoms at all after. No treatment needed. Will call client later today and check on client again to make sure he is still doing okay.
After receiving  the booster (3rd) dose of moderna covid vaccine on 11/29/21, the patient began to develop a rash a few days later.  The rash worsened, so patient went to his PCP who put him on oral steroids.  A few days later the patient developed enteritis and was admitted to this hospital.   He was hospitalized for 5 days/4 nights and then released home.  He returns today with significant swelling and pain in multiple joints - unable to ambulate.