chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FELT LIKE DEATH; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, the company unable to perform follow up to batch numbers. No concomitant medications were reported. On an unspecified date, the subject experienced felt like death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt like death was not reported. This report was non-serious.; Sender's Comments: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
left ankle is very swelling, redness, it's very painful; left ankle is very swelling, redness, it's very painful; left ankle is very swelling, redness, it's very painful; This is a spontaneous report from a contactable physician (patient).   A 66-years-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Batch/lot number unknown, intramuscularly from an unspecified date (at the age of 66-years old) as a single dose (reported as I think it was 0.5 ml they gave me some card, normally it is 0.5 ml I believe, I don't know) for covid-19 immunization.  Medical history included mild hypertension for which he was on blood pressure very low dose like 50 mg from an unknown date and unknown if ongoing.  The patient is very active, four days of gym. He is not obese, not a smoker and doesn't drink. Concomitant medication included losartan.  The physician reported he worked for the hospital so was exposed to COVID-19 patients. The hospital offered the COVID-19 vaccination and he got it on Friday like 1 O clock on unspecified date and since this morning like 3am (03:00) on unspecified date, his left ankle is very swelling, redness, it's very painful. He read about the side effect its says joint swelling. "I never had problem like gout or any degenerative joint disease". He was healthy.  He doesn't know if this is related with this. He was going to call the hospital. The physician further he never have swelling like this, he doesn't know what exactly happened. He cannot say 100 percent but nothing happened, he did not take any new medicine. He doesn't have any injury. He never had gout.  He never have any degenerative joint disease. "I cannot say 100 percent but there is a possibility."  For treatment the physician stated, "no, it happened 3 am in the night since morning I am doing hot, I have put heater in front of my feet." The patient did not have lab work performed.  He was thinking to go ask hospital to rule out any gout, any arthritic pain, "I am going for arthritic". Outcome of the events left ankle is very swelling, redness, it's very painful was unknown.   The lot number/batch for the vaccine, BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, was not provided and will be requested during follow up
Pt rec'd 2nd dose of vax & developed abd cramping, v,d; sx remitted spontaneously in 9 days; Vaccinated w/1st dose of Hepatitis B vax w/out adverse experience;
On-call physician took call from mom at 10:15pm. Within 45 min of vaccine face was red, then at night developed large hive on (L) cheek. Mom gave BENADRYL and child went to sleep. Never had any respiratory symptoms.
Mother brought pt into clinic one day after vaccine administration. Pt has red hard swollen (Rt) arm in tricep area about 4" across. Denies temperature complaining of arm hurting. Instructed mom that this reaction can happen in a varicella booster to treat symptom with TYLENOL or ADVIL and BENADRYL. Instructed mom on what could require an ER visit & asked her to call me on 8-27-12 with update. Mom has not called back yet. 8/27/12 1400 hr.
following the vaccine she had migraine for 2 days then the third day she developed severe cough with difficulty breathing. wheezing lasted 3 weeks. had negative covid test at cvs. patient was seen at er. also negative covid test at ER. she was given steriods, albuterol inhaler in the ER then regular doctor added azithromycin.
Chills and muscle aches 3 hours post FLU vaccine. Treated with ADVIL, chills returned at 5pm, Treated with ADVIL and TYLENOL.
Headache; Vaccine route of administration is intravenous; Slight pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 69-year-old female patient received BNT162B2 (BNT162B2), intravenous, administered in arm left, administration date 24Feb2021 01:30 (Lot number: EL6203, Expiration Date: 02Jun2021) at the age of 69 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162B2 (Dose 1, single (Batch/Lot number: EL9264, Expiration Date: May2021) via intravenous in the left upper arm at 12:00 PM), administration date: 03Feb2021, when the patient was 69 years old, for Covid-19 Immunization, reactions: "Headache", "Sinus congestion", "Cough", "Fatigue", "Slight pain at injection site", "Vaccine administered via IV". The following information was reported: HEADACHE (non-serious) with onset 24Feb2021 07:30, outcome "recovered" (24Feb2021 17:30), described as "Headache"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Slight pain at injection site"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 24Feb2021 01:30, outcome "unknown", described as "Vaccine route of administration is intravenous".  The reporter considered "headache" and "slight pain at injection site" not related to BNT162B2.  Additional Information: The patient did not receive any recent vaccines for any other conditions and for SARS-COV-2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination.  No follow-up attempts are possible. No further information is expected; Sender's Comments: Based on the close temporal association the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out ,Linked Report(s) : US-PFIZER INC-2021120725 Same patient and product; Different dose and events
pt recv vax 1DEC96 & 3NOV97 pt devel a case of chickenpox & was hosp;devel greater than 100 lesions & a temp of 104.8;
Information has been received from a registered nurse concerning a 5 year old female patient with no pertinent medical history, who on 13-NOV-2007 and on 03-MAR-2012, was vaccinated with the first and second dose of VARIVAX (Merck) (doses, routes and lot numbers not reported). There was no concomitant medication. It was reported that, on 01-MAY-2012, the patient developed chicken pox described as mild, about 50 papules scattered all over the body without vesicles, just a macular papular rash. The patient sought unspecified medical attention ("nurse"). No treatment was given for the symptoms. No diagnostic studies were performed. At the time of the report, the patient's outcome was recovering. This is one of the several reports from the same source. Follow-up information as received from a nurse refers to female patient with no illness at time of vaccination and no adverse events following prior vaccination. No other co-suspects were reported. No concomitant medications were reported. It was reported that on 03-MAY-2012, the patient experienced broke through disease after "2 varicella vaccines". On an unspecified date the patient recovered. Additional information is not expected.
Diffuse Musculostreleted pain and weakness. Skin desquamation @ fingers; Dermatitis @ head.  7/23/09 Received hospital medical records for 7/4-7/10/2009. FINAL DX: myalgias & muscle stiffness, etiology unknown, possible reaction to anthrax vaccine or Augmentin, possible stiff person syndrome; small splenic infarcts, unkown cause, nonalcoholic hepatic steatosis w/bridging fibrosis. Records reveal patient had several recent illnesses w/hospitalizations.  Initial symptoms had occurred approx 2 weeks s/p anthrax vaccine having flu-like symptoms of fever, myalgias, arthralgias, swelling of right submandibular area, SOB & pleuritic chest pain.  Ttx w/Augmentinfor presumed salivary gland infection, initially improved then worsened.  Admitted to outlying hospital for approx 2 wks w/extensive w/u which revealed pulmonary effusions & splenic infarcts all thought to be related to Augmentin allergy.  Tx w/IV antibiotics & antivirals & improved. D/C on 7/1 w/o clear diagnosis.   After d/c, patient developed fever, chills, fatigue, diffuse musculoskeletal pain, stiffness & weakness, difficulty walking, peeling skin on fingers, continued vesicular itchy scalp rash, loss of appetite, 20# weight loss in 2 weeks, diarrhea x 3 wks while on antibiotics, icteric.  ID & Derm consults done.  Exam revealed scalp & fingernail rash.  Proximal more than distal muscle weakness.  C. diff tx w/oral antibiotic.  Splenic infarcts tx w/anticoagulant therapy.  Remained stable but still symptomatic at d/c to home w/PCP, Neuro & Hepatology referrals.  10/13/09 Received hospital medical records and discharge summary for dates of service 6/22/09-7/1/09.  Dx:  Acute febrile illness of unknown cause associated with sialadenitis, diffuse pulmonary infiltrates with hypoxia, elevated liver function tests, thrombocytopenia.  Possible atypical viral infection.  Possible adverse drug reaction to clavulanic acid. Possible adverse reaction to anthrax vaccine.  Possible bilateral lower lobe pulmonary emboli.  Small splenic infarctions of undetermined cause.  Assessment:  Pt. developed swollen submandibular gland or lymph node 4 days prior to admission with fevers to 102 degrees.  He was treated with Augmentin by his PCP and initially improved for 2 days, then developed recurrent high fever.  In the ED he was tachypnic and tachycardic, with an O2 sat of 89% on room air, hypoxemia.  Given supplemental O2.  Leukocytosis, anemia and thrombocytopenia present at admission.  The pts. main symptoms were breathlessness and pleuritic chest pain over the course of the hospitalization. Treated with low molecular weight heparin and started on warfarin for pulmonary emboli. Patient discharged home in a stable, weakened condition.  ICD 9 Codes:  780.60, 415.19, 584.9, 527.2, 289.59, 287.5, 511.9, 571.8, 401.9, 518.0, 053.9, 780.6.
a little bit of soreness in the arm at the injection site; This is a spontaneous report from a contactable consumer (patient's husband). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the arm on 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had no side effects aside from a little bit of soreness in the arm at the injection site in Jan2021 with outcome of unknown.  Information on the batch/lot number has been requested.
Fractured Hip Bone; fell out of an chair; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  An 85-year-old female patient received bnt162b2 (BNT162B2), on 17Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 84 years for covid-19 immunisation; bebtelovimab (BEBTELOVIMAB), on 25Apr2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (Dose 1, Lot: EL9263), administration date: 30Jan2021, when the patient was 83-year-old, for COVID-19 immunization; bnt162b2 (Dose 2, at 3:30 PM), administration date: 20Feb2021, when the patient was 83-year-old, for COVID-19 immunization. The following information was reported: HIP FRACTURE (medically significant) with onset 09Dec2022 at 17:00, outcome "unknown", described as "Fractured Hip Bone"; FALL (medically significant) with onset 09Dec2022 at 17:00, outcome "unknown", described as "fell out of an chair". Therapeutic measures were taken as a result of hip fracture.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300298831 same patient, different events and doses;US-PFIZER INC-PV202300153749 same patient, different events and doses;
Patient recieved afluria at 4:21pm on 10/16/2020. He checked the "no" box in the questionaire " have you had a seizure or a brain or nervous system problem or guillain barre?" He was at the pharmacy until 4:41pm waiting for an additional prescription or 20 minutes after the flu shot was given and he did not have a seizure. On 10/18/20, his father called and explained that he was in the icu because he had a seizure on 10/16/20 at 6pm or 1.5 hours after the flu shot.
Patient hasn't received 2nd dose yet; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet) 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 PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.
PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included difficulty in hearing, and difficulty in communication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2068219, expiry: UNKNOWN) dose was not reported, administered on 22-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 22-JUN-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain at injection site on 23-JUN-2021. This report was non-serious.
Very similar to previous effects. High temperature that night, followed by hypothermia (<95F) for two weeks. Dizziness, weakness, light headed, left side of face  is now about 50% numb rather than 33% (feels swollen/tingling), possible slight drooping left side of mouth, possible slight hearing loss left side. Loss of ability to mentally visualise at all has not changed since first dose
Information has been received from a consumer concerning her son, a 6 month old male who on 10-JUL-2008 was vaccinated with his third dose of ROTATEQ (Lot # not reported).  The consumer reported that her son had received his third dose of ROTATEQ on 10-JUL-2008.  Approximately 24 hours after receiving dose, the patient experienced intussusception.  The patient was rushed to the emergency room and needed surgery.  He was hospitalized from 11-JUL-2008 to 16-JUL-2008.  ROTATEQ was not reintroduced.  The patient was considered to be not recovered.  The reported considered intussusception as an other important medical event.  There was no product quality complaint.  Additional information has been requested.8/4/08-records received for DOS 7/16-7/22/08-DC DX: Intussusception. Laparotomy, small bowel resection, incidental appendectomy. Presented with C/O oen day history of fever, abdominal pain with intermittent crying, vomiting and blood in stool. Fussiness and abdominal distension.
severely sore arm; injured a ligament in the shoulder; Unable to lift arm; pain in shoulder and muscle; pain in shoulder and muscle; This is a spontaneous report from a contactable other healthcare professional (hcp). A 26-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry date not reported), intramuscular on 07Jan2021 08:45 at a single dose in the left arm for COVID-19 immunization. Medical history included allergic to tree nuts and patient had COVID prior to vaccination. The patient was not pregnant at the time of the vaccination. Concomitant medication included tetanus vaccine on 02Jan2021 at a single dose. The patient had no other medications in two weeks. On 10Jan2021, the patient experienced severely sore arm as well as feeling as though patient injured a ligament in the shoulder. The patient was unable to lift arm without pain in shoulder and muscle. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Treatments was not received in response to the events. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events severely sore arm, injured a ligament in the shoulder, unable to lift arm, and pain in shoulder and muscle.  Information on the lot/batch number has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient was inoculated with ZOSTAVAX on or about 02-OCT-2013, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 05-FEB-2016 the patient was treated at his Primary Care Physician's office for the onset of severe residual pain in the area where shingles pustules has been. The patient was diagnosed with post-herpetic neuralgia, a chronic condition of nerve damage secondary to herpes zoster. On or about 01-APR-2016 the patient was treated again by the physician for continued and worsening symptoms of nerve pain, at which time the diagnosis of neuralgia was affirmed and stronger medication was prescribed. On or about 27-JUL-2016, the patient underwent continued treatment for worsening symptoms, which was then diagnosed as post-herpetic neuropathy. The patient has been prescribed oxycodone, NEURONTIN, LYRICA, FAMVIR and PERCOCET. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
Received the 3 vaccines on 06/18/2021, approximately 1 week afterwards started to develop rash to body worsening over time with no improvements now has rash to Head/Neck region, both eye lids, both limbs abdomen, back of knees and lower legs.  Denied shortness of breath or difficulty breathing. Has no PCP at the time. was seen today at a Walk-in clinic. Not poison oak per Health Provider.  Given injection of Cortisone and a oral preparation was also referred to a Dermatologist for follow up care.
Redness & swelling of left arm to elbow-area hot, was itching but no longer-patient is improving.
pale; itchiness; redness 4-4.5 inches in diameter around the injection site; swelling around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), INJECTION SITE ERYTHEMA (redness 4-4.5 inches in diameter around the injection site), INJECTION SITE SWELLING (swelling around the injection site) and PALLOR (pale) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ANTIBIOTICS for Rosacea, LEVOTHYROXINE SODIUM (SYNTHROID), SPIRONOLACTONE and GABAPENTIN for an unknown indication.    On 02-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PRURITUS (itchiness), INJECTION SITE ERYTHEMA (redness 4-4.5 inches in diameter around the injection site) and INJECTION SITE SWELLING (swelling around the injection site). On 18-Jan-2021, the patient experienced PALLOR (pale). On 15-Jan-2021, INJECTION SITE SWELLING (swelling around the injection site) had resolved. At the time of the report, PRURITUS (itchiness) and INJECTION SITE ERYTHEMA (redness 4-4.5 inches in diameter around the injection site) had not resolved and PALLOR (pale) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included hydrocortisone cream 3-4 times a day for a week
Significant local reaction reaction w/signs of infections several days after Td immunization, Rx with antibiotics.
Information has been received from a pharmacist referring to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot # M034766 with expiration date of 26-OCT-2017, dose and route unspecified). On an unknown date, after receiving the vaccination, the patient experienced difficulty breathing, numbing of the mouth, vision loss, dizziness, a weird taste in her mouth, and high blood pressure. The patient had to go to an unspecified emergency room. At the reporting time, the outcome of the events was unknown. The causality between the events and ZOSTAVAX was not reported. The pharmacist requested a lot check for this lot number of ZOSTAVAX. Upon internal review, vision loss was considered to be medically significant. This is one of three reports received from the same reporter. Additional information has been requested.
Local redness and tenderness. 5 cm diameter. Local firmness developed over next day.
For each shot same side effects. Arm sore 2 days muscles aches 36 hours. However, February 24, 2022 afebrile but got raspy throat which advanced into cough, congestion mild headache and tiredness over 2 days. 2/26 at home tested negative for COVID. Tuesday 2/28 loss of taste and smell re-tested and positive for COVID. Improvement started 3/1. 3/3 congestion improved, still headache and tiredness. 3/6 re-tested positive for COVID (5 days post 1st symptoms. 3/7 contacted Dr. and told to continue isolation for total of 10 days post 1st positive test i.e. through 3/10. Retested on 3/10 negative for COVID (confirmed with 2 different manufacturers home test).
Mother stated that child was having respiratory difficulty, fever tmax 101.9.  Pt was given IV antibiotics to rule out bacteremia.  08/15/2008 MR received for DOS 5/17-20/2008 with D/C DX: Fever, r/o bacteremia.  Also suspected the chance of being reaction to the vaccines. Pt presented to ER with high fever beginning several hours after receiving vax and an episode of difficulty breathing. Admitted for sepsis w/u. Tx with abx until cx (-). Pt quickly became afebrile with benign exam.
Narrative: COVID infections following completion of COVID vaccine series 03/11/21 COVID vaccine dose #1 04/05/21 COVID vaccine dose #2 07/30/21 Pt presents to ED reporting eye redness, denies pain, headaches, or blurry vision; discharged home with ofloxacin sys drops for empiric treatment for conjunctivitis; COVID POSITIVE 08/02/21 Pt reports he had a runny nose that has resolved and a very slight cough that occasionally occurs at night 08/04/21 Pt reports fatigue, runny nose 08/06/21 Pt reports he is asymptomatic; clinically resolved