chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow up information has been received from a registered nurse concerning a 17 week old (also reported as 16 week old) male with no known drug allergies or adverse drug reactions and a history of a prior hospitalization (09-Mar-2005) and prior immunizations on 09-Mar-2005 with diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (Tripedia) (Lot # CL614AA), poliovirus vaccine inactivated (Vero) (Ipol) (Lot # W0750), unspecified hepatitis B virus vaccine (Hep B) (Lot # ENG5521A2 and on 16-Mar-2005 immunizations with unspecified Hib vaccine (Hib) (Lot # UE206AA) and pneumococcal 4 6B 14 18C 19F 23F conj vaccine (CRM197) (Prevnar) (Lot # A74400A). On 20-Apr-2005 the patient was vaccinated intramuscularly into the right thigh with a 0.5 ml dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (Lot # 643887/0739M) instead of Hib conj vaccine (OMPC). Concomitant suspect therapy, that same day included the second 0.5 ml dose of poliovirus vaccine inactivated (Vero) (Ipol) (Lot # W0750) administered intramuscularly into the right thigh and the second 0.5 ml dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar) (Lot # A74400A) administered intramuscularly into the left thigh. Other concomitant therapy included the second 0.5 ml dose of diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (Tripedia) (Lot # U1290BA) administered into the left thigh in April 2005. On 21-Apr-2005, it was reported that the patient's "leg was a little sore" like the last time the patient was immunized. On 22-Apr-2005 the patient's mother reported that the baby was "doing fine." It was previously reported that the patient sought unspecified medical attention. The patient's present status was noted as "unremarkable." No further information is available.
Injection placed in improper site - right lateral hip. No pain on injection, hours later started to have chills, pain, redness, swelling, itching, general malaise
Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 72-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       Concomitant medications were not reported.  Patient reported there was something wrong inside patient's chest and patient could only hope it was not one of those forever symptoms like (long covid).  Treatment medications were not reported.
Fever after the vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever after the vaccination) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever after the vaccination). At the time of the report, PYREXIA (Fever after the vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment was reported.
soreness at the site of application; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "soreness at the site of application". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: After the first dose, the patient felt some soreness at the site of application on the first day, she put some ice and the next day she felt better. She thought the nurse "put it so high", where the clavicular bone meets her arm, an inch below that, she thinks its a little high for the vaccine. The patient (Retired Registered Nurse) is scheduled for a colonoscopy had the procedure to be done by gastro-endocrinologist (further clarification unknown). It will be on March 18th on 9am at the clinic or hospital, she don't know. On the 19Mar, the next day at 12noon, the patient was scheduled for second dose of Covid Vaccine. It was reported LOT# and Expiration date: Nurse stated, "It was lost." Asking was the vaccine administered on the deltoid muscle? and can she get the vaccine after the 21 days?.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Had injection 04/29/04 on 04/30/04 pt woke up with rash and around inj site very red and hard. 5 inch diameter with scattered urticaria elsewhere. No SOB, no angio edema. ON 04/29/04 had Benadryl before injection.
This child received 2 doses of Varicella vaccine per appropriate schedule. 08-23-04 dose 1 and 08-19-08 dose 2. Developed rash consistent with chickenpox lesions > 100+ in 02-09
initially: sharp pain at injection site for several weeks. transitioning to more general ache over larger area of left arm.  currently: ache in upper arm near injection site, inability to put weight on shoulder for more than a few minutes due to increasing pain, occasional discomfort (perhaps numbness) extending to lower arm and wrist.
Narrative:  72yo male patient died on 10/13/2021. Pt had received J&J covid vaccine on 3/8/21 at non agency pharmacy. Pt with past medical hx: I25.10 Coronary artery disease (SCT 53741008) I10. Essential hypertension (SCT 59621000) E78.5 Hyperlipidemia (SCT 55822004) K21.9 Gastroesophageal reflux disease (SCT 235595009) J43.9 Pulmonary emphysema (SCT 87433001) I50.32 Congestive heart failure (SCT 42343007) M25.512 Pain of left shoulder joint (SCT 15916971000119109) M25.511 Pain of right shoulder joint (SCT 15917011000119100) M25.552 Pain of left hip joint (SCT 316781000119100) F43.10 Posttraumatic stress disorder (SCT 47505003) Likely this death is not related to covid vaccines given patient's age, comorbidities, and long length of time between date of vaccines and date of death.
pt states had headache on right side of head on and off ten minutes after receving vaccine, then noted to feel dizzy as well  brought back to OBS area via wheelchair for further evaluation   pt transferred self to stretcher low fowlers on stretcher vs as noted.   pt feeling better once laying down. pt given water and gradually repositioned self to sitting up, dangle at bedside to standing without further symtpoms or complaints.  pt feeling better  feeling okay to leave ambulated to exit at 1608  vs 1555 hr 75 bp 141/97 po 100  1600 hr 72 bp 133/90 po 100,  1504 sitting up, hr 70 po 100 bp 146/100   1606 dangle hr 64 bp 146/91 po 100
Headache, Nausea, Chills, achy joints & muscles, Rash on stomach, inner elbows, armpits, behind the knees, large hot/red spot about 3 inches below the injection site, swelling of the left arm between shoulder and elbow including injection site
Chills; Fatigue; This is a spontaneous report from a contactable consumer. This consumer reported 2 reports for different patients (herself and her husband). This report is for herself. A 70-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced chills and fatigue the day after vaccination when she woke up for a few hours.  The information on the lot/batch number has been requested.
it feels very warm and I feel warmer; I feel my urine was like pinkish now it is getting worse and now I get come out with blood, Urine with blood; little bit pain now it pain more and it come out with blood; Pain with blood and this is very painful and it make me sticky; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Mar2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: BLOOD URINE (non-serious) with onset 17Mar2023, outcome "unknown", described as "I feel my urine was like pinkish now it is getting worse and now I get come out with blood, Urine with blood"; DYSURIA (non-serious) with onset 17Mar2023, outcome "unknown", described as "little bit pain now it pain more and it come out with blood; Pain with blood and this is very painful and it make me sticky"; FEELING HOT (non-serious), outcome "unknown", described as "it feels very warm and I feel warmer".  Additional information: Consumer had the Booster shot (Clarified as Pfizer COVID 19 Booster shot) yesterday (as reported) morning and then last night felt the urine was like pinkish now it is getting worse and now come out with blood, Urine with blood. After took the Booster shot yesterday morning and it start last night there start to be little bit pain now it pains more and it come out with blood. Doesn't have like that before and it feels very warm/feel warmer.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient received booster COVID vaccine at outpatient pharmacy clinic. 20 minutes after receiving the injection the patient reported mild light headedness. Patient denied any shortness of breath, tongue swelling, rash. Patient's vital signs stable. Patient's symptoms improved with hydration and rest. Patient able to stand and ambulate without symptoms. Patient discharged home, accompanied by spouse.
The patient was vaccinated underage at 15 years of age. No adverse reaction noted, pt. felt well.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Between November 2014 and 03-DEC-2014 the unspecified number of patients was vaccinated with unspecified number of doses of improperly stored GARDASIL (doses, indications, route of administration were not reported). The nurse did not know whether any patients experienced any adverse effects. This is one of several reports from the same reporter. Additional information has been requested.
This was my youngest to receive vaccine. I told pediatrician office but not sure they reported it. Now younger kids are recommended, I just want to share our experience. My son was 3 days away from 14 years old and healthy. After receiving Pfizer vaccine my son felt fine. However after falling asleep at night, he woke a few times with his body twitching and shaking. His jaw felt hard to talk. After that no other symptoms that I'm aware of.
This spontaneous report as received from a patient's mother via a company representative refers to an 18 year old female patient. The patient concomitant medications, medical history and drug reactions or allergies were unknown by the reporter. On unknown dates, the patient was vaccinated with doses of GARDASIL for routine vaccination (doses, site, route of administration,  lot # and expiration date were not reported). The patient completed the series of vaccination in approximately 2016 (reported as about one year ago). On unknown dates, patient experienced three different seizures. One of those seizures was severe enough that the patient was admitted to the hospital for one day (start date of hospitalization was not reported). On an unknown date, the patient had  some unspecified neurological tests performed but results were not provided (reported as"inconclusive"). Based on the test it was suggested that the seizures occurred as a result of either the GARDASIL vaccination or there was a possibility that the patient might have smoked some bad marijuana  (reported as "some really bad pot"). On an unknown date, the patient also had a computerized tomography (CT) scan, which results were unknown. The patient had a seizure "recently" and might or might not experience additional seizures moving forward. The outcome of the event was unknown. The relatedness between the event and GARDASIL was not reported. Upon internal review, the event of seizures was considered to be medically significant. Additional information has been requested.
ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY ACUTE STROKE DUE TO OCCLUSION OF UNSPECIFIED ARTERY 2/9/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
I had a Coronary Artery Spasm which led to a Heart Attack. on 3/13/21 at 6:30 am at home. I was stabilized in the Ambulance with sublingual nitroglycerin. The Coronary artery was blocked. The Dr. did a Heart Catheterization which showed that the blockage had receded and no further procedure was performed. I spent 2 Days in Hospital having another heart spasm on 3/14/21 at 05:00 pm which was relieved by Nitroglycerin. I was released and experienced 8 more episodes over the next week. I have been prescribed Calcium channel blockers, blood thinner, and cholesterol drugs as treatment I have constant aching and 2 more episodes requiring Nitroglycerin last week.  I do not have high blood pressure   heart disease or coronary artery disease
Muscle Pain (All Body) Sat. 1pm-Sun End of Day Fatigue (All Body) Sat. 1pm-Mon. 6am Cold Chills Sat. 1pm-Sun. 10am. Dizziness Sat. 1pm-Sun. 10am. Nausea Sat. 1pm-Sun. 10am.
Within 36 to 48 hours the pt developed fever of 102 degrees and an injection site reaction on the Pnu-Imune administration site characterized by a 10 cm to 20 cm area of swelling and redness of his right arm.  His white blood cell count was 17,500/mL.  He was prescribed an oral antibiotic.
The evening after his vaccination, patient developed a low grade fever 100.2F, agitation and restlessness while trying to sleep, fatigue and malaise.
Headache began 28 Feb, unrelieved with ibuprofen. 1 March took 600 mg of ibuprofen every 6 hours, did not relieve headache. Continued until 2 March when vomiting began. Went to the ER 2 March. Received decadron, Benadryl, inapsine, toradol, compazine, and IV fluids. ER prescribed me zophran. Took zophran twice on 3 March, but vomiting persisted. Vomiting continued 3 and 4 March. Appointment with PA 4 March. Given phenergan and sumatriptan. Vomiting resolved 4 March with phenergan. Headache finally resolved 5 March after a dose of sumatriptan.
No adverse events, treatment, outcome(s) or symptoms occurred from patient recieving the expired vaccine.
I had a stroke at  5:00 A.M. on May 8th wich was 3 days after the second booster shot. I was flown to Clinic. Doctors did a CT and MRI and could not find what had caused the stroke.They mentioned two times they would like to find the cause to try to keep it fromhappening again.  I went from the clinic to a rehabilitation hospital.
patch on your arm shaped like a square of 2x2x2x2 that red in the middle and the outside edge is yellow and blue like a tattoo,  it was hard the first then, a little tender but mostly reddish, square and yellowish blue brushing.
Back cramps could not lift arms past neck; Back cramps could not lift arms past neck; Complete numbness in both arms and hands/finger tips in right hand still numb; Complete numbness in both arms and hands/finger tips in right hand still numb; Complete numbness in both arms and hands/finger tips in right hand still numb; This is a spontaneous report from a contactable consumer (Patient) .  A 51-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 15Apr2021 09:00 (Batch/Lot Number: Er8734) as SINGLE DOSE for covid-19 immunisation  .  Medical history was none. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, Lot number En6205, Administration date on 25Mar2021 at 10:30 AM on left arm for covid-19 immunisation. Patient did not have COVID-19 prior to vaccination. There were no concomitant medications.  The patient experienced back cramps that patient could not lift arms past neck, complete numbness in both arms and hands on 15Apr2021 20:00 with outcome of recovering , complete numbness in both arms and hands(hypoaesthesia) (disability) on 15Apr2021 20:00 with outcome of recovering. The patient added that a week later finger tips in right hand were still numb (outcome recovering). The events resulted in doctor's office/clinic visit with seriousness of disability or permanent damage. The patient was not tested positive post vaccination.
Information has been received from a certified medical assistant (C.M.A) referring to a child patient of unknown age and gender. No relevant history or concurrent conditions were reported. On an unknown date the patient was vaccinated with improperly stored   ROTATEQ (lot # K004468, expiration date 08-DEC-2015, 2ml oral). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Nausea; pale diarrhea; gas; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03May2021 at 16:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus, hashimoto's thyroiditis from an unspecified date. The patient had no known allergies. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), insulin degludec (TRESIBA), insulin lispro (HUMALOG) from an unknown date for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown as a single dose for COVID-19 immunisation. 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 04May2021 at 06:00 the patient experienced nausea, gas, and pale diarrhea still 4 days after 2nd dose. The patient did not receive treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events nausea, diarrhea, gas was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Second dose was scheduled for 04MAY2021, but she did not receive it due to the advice of her doctor; Started noticing a rash / the rash kept getting worse; 103 fever; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Second dose was scheduled for 04MAY2021, but she did not receive it due to the advice of her doctor), RASH (Started noticing a rash / the rash kept getting worse) and PYREXIA (103 fever) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Second dose was scheduled for 04MAY2021, but she did not receive it due to the advice of her doctor), RASH (Started noticing a rash / the rash kept getting worse) and PYREXIA (103 fever). At the time of the report, OFF LABEL USE (Second dose was scheduled for 04MAY2021, but she did not receive it due to the advice of her doctor), RASH (Started noticing a rash / the rash kept getting worse) and PYREXIA (103 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103 Fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were mentioned. Treatment medication reported included Two antibiotics, pain medication and steroids. She went to the ER twice. On her second visit she was asked to follow up with her primary care physician who prescribed a steroid for her. The second dose was scheduled for 04MAY2021, but she did not receive it due to the advice of her doctor.
BONE ACHES; SITE SORENESS; MUSCLE ACHE; LIGHT FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced bone aches, site soreness, muscle ache, and light fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bone aches, site soreness, muscle ache, and light fever. This report was non-serious. This case, from the same reporter is linked to 20210949856.
Headache; Nauseous; Fever; Sweat like crazy; Patient heart rate's raising; Freezing; Blood pressure is high; This is a spontaneous report from a contactable consumer (reported for herself). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0176), via an unspecified route of administration on 06May2021 (at the age of 59 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache, nauseous, fever, sweat like crazy, my heart rate's raising, freezing, blood pressure is high on an unspecified date. It was reported that the caller is calling to report that she is having the symptoms after getting the first dose. The first dose was administered on 06May2021, and the second dose was scheduled on 27May2021. After getting the first dose she has the symptoms like headache, cold freezing and nausea. Consumer stated that her question was how long this going, this side effect, she was freezing. When probed for further questions consumer stated she had some side effects with the Pfizer covid vaccine. She had fever but she sweat like crazy then she freezes and got really nauseous and my heart rate's raising and blood pressure is high. The patient underwent lab tests and procedures which included heart rate: increased on an unspecified date. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information was expected.