chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; Plantar fasciitis; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4535813-00ff.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 12Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 51 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) at citrate free, subcutaneous for rheumatoid arthritis, ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PLANTAR FASCIITIS (non-serious) with onset 2022, outcome "recovering"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The action taken for adalimumab was dosage not changed.  Clinical course: Duration was 4 weeks. On an unknown date, the patient experienced covid virus. In 2022, the patient experienced plantar fasciitis. Pfizer biontech covid-19 vaccine (tozinameran) Was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. Action(s) taken with BNT162b2 was Unknown.  The reporter's assessment of the causal relationship of "covid-19" with the suspect product(s) BNT162b2 was probable and "plantar fasciitis" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The reporter's assessment of the causal relationship of "covid-19" and "plantar fasciitis" with the suspect product(s) HUMIRA (adalimumab) was not provided at the time of this report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events Vaccination failure, Covid-19 and Plantar fasciitis cannot be excluded for the suspect drug. The case will be reassessed once new information is available.
Subject has localized skin reaction following the Moderna COVID-19 vaccine.  Patient received vaccine at 10:07 on 1/4/21.  Subject states reaction of red, warm, patch, itchy skin started on 1/12/21 at vaccine site.  Vaccine was delivered to left arm.  Patient states she may have had hives as well.
pt recv vax 29DEC96 & devel itchy, red hives on neck;pt recovered;
Headache, Fever, NauseaVomiting, SWEATS, SHILLS Narrative:
Emergency Room visit - 10/5/09 - one hour after vaccination. Symptoms - dizzy, weakness - diagnosed with possible allergic reaction. Rx with IV Prednisone and BENADRYL.
shortness of breath; chills; headache; This is a spontaneous report from a contactable consumer (patients wife). A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot number: Not reported), via an unspecified route of administration on 06Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced shortness of breath, chills, headache. Her husband received the COVID-19 vaccine at the same time (he had no previous COVID-19 diagnose) he also developed shortness of breath, chills and headache, he stayed in bed for two days after which he recovered completely, caller has presented these side effects for more than 12 days. The patient had taken Ibuprofen and Acetaminophen to treat the chills. The outcome of events was recovered on an unknown date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt had brief syncopated event roughly 5 minutes post vaccination.  Lost color in face, pt stated visual changes.  Pt mother was seated next to patient and supported pt as she fell to one side while seated.  Pt came to within one minute.  Gave pt ice water, nuts and a snickers bar, offered to have pt lie down with elevated feet, but pt declined.  Ice water and nutrition helped pt feel better and color returned.  Pt stated they ate breakfast, but little to no lunch prior to vaccination at 3:30pm.  Pt sat upright until snacks and water were consumed, pt felt well enough to stand on her own after roughly 15 minutes of being seated.
41/ YEAR OLD FEMALE COMPLAINEDOF TROUBLED BREATHING 10 MINUTES AFTER RECEIVING VACCINE. ON SITE EMS RESPONDED, VITALS BELOW. AFTER BEING MONITORED SHE WASN'T FEELING BETTER AND WAS TRANSPORTED TO RECEIVING HOSPITAL VIA EMS.
Initial solicited report on 13 March 2017 from an investigator (Defense Health Agency/Immunization Healthcare Branch) in the trial. A 22 year-old male subject with no significant medical history. The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number and route, site of administration not reported) on 28 November 2016. On 12 December 2016, 14 days after vaccination the subject was diagnosed with I30.9 acute pericarditis, unspecified. The subject's lab data included, on 07 December 2016 ECG and Echocardiogram was normal. Troponin I result - 03.11, Abnormal. Treatments were not reported. The subject's outcome was not reported. Relationship to investigational product according to company: associated. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety urveillance (data mining, non-interventional) study. List of documents held by sender: none. Sender's Comments: This case involves a healthy 22-year-old male who developed acute pericarditis with favorable temporal association post vaccination with ACAM2000. Pericarditis is a listed adverse event that may occur following vaccination with live vaccinia virus smallpox vaccines. Alternative etiologies could be Myocardial infarction, pulmonary embolism, Pneumonia, Costochondritis or pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, biopsy, role of study vaccine can not be ruled out.
1258 Called to lobby. Pt pale, diaphoretic, and having tremors of extremities. Per mom he does this with vaccines. She did not say anything thinking it was psychological and if she did not mention it he would be OK. C/O dizzy. Transferred by parents to wheelchair then to treatment room. Two person standby assist to treatment table and lying in supine position. Verbalizes had not eaten and feels better lying down.  1300 VS 117-67 HR 76, Resp 14, O2 sat 97% room air.  1314 Skin color improving. Skin dry. Assisted to sitting position. 1315 VS 116/71 HR 71 R 14 O2 sat 98% room air. Dad assisted with ambulating to lobby waiting area. Instructed to sit for 20 min and will reassess. If dizziness returns to not stand up and let parent know. Verbalizes understanding
Patient has a fever of 100.4 and has had that for the last 3 days. Also has a red warm rash on left upper arm, that patient states has gotten bigger over the last couple days. She did state she applied Calamine lotion and took ADVIL which helped it to feel slightly better. Recommended she goes to her physician or an Urgent Care/After hours to be seen if could not be seen by primary care physician for a check up.
Initial medication error report received on 04 October 2013 from a nurse. A 11 years old unknown patient whose gender, medical history and concomitant medications were not reported, received a dose of FLUZONE ID (route, lot number and site of vaccination was not reported) on an unspecified date. Drug was given to an 11 year old. List of documents held by sender: none.
PERSISTENT CENTRAL NERVOUS SYSTEM INFLAMMATION; This spontaneous report was received via literature: This report concerned a 43 year old female of an unspecified race and ethnicity. The objective of this study was to report a case series of 3 patients who developed neuro-inflammation following administration of the J and J vaccine. Spinal cord was involved in all 3 patients, brain in 2, and peripheral nervous system involvement (facial nerve enhancement, radiculitis) in 2 patients. 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, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. 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, approximately 4 weeks after vaccination, the patient experienced persistent central nervous system inflammation. It was reported that approximately 4 weeks after vaccination, the patient developed progressive gait difficulty and ascending paresthesias in bilateral lower extremities. Laboratory data (dates unspecified) included: CSF (Cerebrospinal fluid) test unremarkable, except for matching bands in CSF and serum, and Magnetic resonance imaging revealed multiple enhancing cervical and thoracic cord lesions and one small enhancing subcortical brain lesion. On an unspecified date (three months later), patient developed symptom recurrence with persistent enhancement and enlargement of one cord lesion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent central nervous system inflammation. The authors concluded that central and peripheral nervous system inflammatory involvement without clear alternative explanation can rarely be seen in close temporal relationship to administration of the J and J covid-19 vaccine. Unusual feature of this cases was clinical/radiographic worsening and persistent enhancement several months after initial presentation. This report was serious (Other Medically Important Condition). This case, from Same Literature article is linked to 20221219487 and 20221219559.; Sender's Comments: V0: 20221218576-persistent central nervous system inflammation.. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Pt rec. vaccine on 2/24, called office on 2/25 reporting 'large read area' @ site of injection T99.  2/26 reports still red, hot, tender to touch.  2/27 Still red, hot, tender to touch (area of redness approx 4 in X 6 inch per mother) or to check on 2/27/09.
sudden onset early AM 12AUG93 of fever 99.4 & red dots on chest, a few on face, a few on arms & legs; went to ER & was told probable rubeola;
Patient passed out and hit head while walking out of the doctors office. He was required to have an emergency head cat scan due to the force of the fall and blow to the head. Patient was "out" for several seconds before coming to. He remained very confused for approximately 30-45 minutes post fall.
Pt received PNEUMOVAX and FLUZONE HD on 10-20-12. Reported pain, swelling, redness at injection site and on anterior antecubital.
Started with itchy throat and coughing. Thought was allergies due to weather. Progressed to a lot of mucus and a lot of coughing (ALOT OF MUCUS in sinuses and lungs. Took sinus medication, allergy medication (night time and day time), ibprofin, musinex, and used vicks, humidifier, air purifier and steam. Symptoms progressed. After approx 2 months started antibiotics. After 2nd round of antibiotics and 1st round of steroids coughing got a little better but did not go away, along with the mucus. Still have a lot of mucus and ears have been plugged up for 2 weeks. Right ear especially (having a hard time hearing). Doctor checked and said there's no inflammation and nothing visually clogging them. Broke out in rash on back and hives all over body 2 days ago. Received steroid shot yesterday and started new steroid pills today.
Experienced significant tachycardia (hr ~140)  beginning about 5 mins from vaccination, lasting ~5 mins.  Self limited.
Starting about a week after receiving the 2nd dose, I started getting excruciating pain. I was balled up on the floor in agony. I passed a kidney stone 2 days later, then the following day I started passing another one. This pattern continued on and is still continuing to this day. I have been to the ER about every 3 weeks to a months time due to the extreme pain I'm having. I've had one kidney stone before but nothing ever like this. It is impacting my daily activities and, while the pain is so severe, I can't do anything.
Doses given after temperature excursion; The vials had 20 mins of temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses given after temperature excursion) and PRODUCT STORAGE ERROR (The vials had 20 mins of temperature excursion) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses given after temperature excursion) and PRODUCT STORAGE ERROR (The vials had 20 mins of temperature excursion). In 2021, EXPIRED PRODUCT ADMINISTERED (Doses given after temperature excursion) and PRODUCT STORAGE ERROR (The vials had 20 mins of temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Itchy, redness at site. One diameter, headache, wheezing, elevated respiration, flu-like symptoms and swollen glands.
Son's girlfriend received positive covid test result 3/22/21, I had developed a runny nose 3/22/21, went to get tested for covid 3/23/21.
Extreme arm pain on 1/7, headache base of skull, 1/7-1/9, Swelling began evening 1/7 in left upper arm. Swelling and upper left arm pain continue, treated with motrin for pain.  Splotches red marks on upper left arm appeared on 1/10, continuing to warmth, deep redness on 1/11 with more severe pain. Sought medical care 1/11 with Dr.
Patient received vaccine 01/06/2009 and called pharmacy 01/14/2009 with complaint of a red rash at the injection site approximately 2 inches in diameter.  Primary care physician prescribed Famvir 500mg twice daily for 5 days.
Large  Red Circle around injection site, tender and warm to the touch, lasted 10 hours then went away.
bad headache and cold chills; bad headache and cold chills; bad headache and cold chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Sep2021 11:00 (Lot number: ep7533) at the age of 12 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Attention deficit hyperactivity disorder" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 ({product=COVID 19, brand=pfizer, ew0176, lot number=pfizer biontech,, lot unknown=False,, administration date=14Aug2021,, administration time=11:00 AM,, dose number=1,, vaccine location=Right arm}]), administration date: 14Aug2021, when the patient was 12 years old, for covid-19 immunization. The following information was reported: HEADACHE (non-serious), NASOPHARYNGITIS (non-serious), CHILLS (non-serious) all with onset 11Sep2021 11:15, outcome "recovered" (Sep2021) and all described as "bad headache and cold chills". Therapeutic measures were not taken as a result of headache, nasopharyngitis, chills.  Additional information: The patient did not have any other vaccine in four weeks and received unspecified other medication in two weeks, patient did not have Covid prior to the vaccination and not tested for Covid test post vaccination.   No follow-up attempts are possible. No further information is expected.
Patient stated that her arm has bothered her ever since the vaccination and that she cannot lift her arm to fix her hair.
Mother stated that patient complained of itchiness to her left lateral thigh which improved overnight. Patient reported to the clinic the following day 10DEC13 will an approximate 60mm erythemic induration to injection site. No other signs or symptoms of allergic reaction observed or expressed by mother.
Child's mother called states that within 10 minutes of receiving vaccine, child c/o headache, nausea and began vomiting. Instructed to take child to his Dr. for follow-up. Parent did not go to Dr. Spoke with her 6-21-12 at 13:10. States child is fine.
PT FELT DIZZY AND COULD NOT SEE CLEARLY. PT CAME TO OBSERVATION VIA WHEELCHAIR WITH WATER AND SALTINES IN HAND. NO S/S OF DISTRESS NOTED. PT VS: 9:59 BP110/66 02 100 RR 16 HR 74  VS9 :05 BP 106/65 RR 17 P 68 02 100 VS9:10 BP 108/74 RR16 P 72 02 100 VS SITTING BP 118/74 HR 75 02 100 VS STANDING BP 99/65 P 91 02 100. PT WAS ESCORTED VIA WHEELCHAIR WITH STAFF. PT WENT HOME WITH HER MOTHER.
This spontaneous report has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions and pertinent medical history were not reported. On unspecified dates, the patients received an improperly stored dose of VARIVAX with a lot # L001327 and expiration date of 13-JAN-2017, lot # L026411 and expiration date of 15-FEB-2017, lot # L038132 and expiration date of 01-OCT-2017, (strength, route of administration and dose were not provided). There was no concomitant therapy reported. No adverse event was reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Client received Pfizer for the first series  on 4/30/21 and received Moderna for second series on 7/12/2021.  Monitored for 15 and no adverse reaction noted.
This spontaneous case report was received from a consumer (PVX2017-1843) on 06-Jun-2017. The report describes a female patient who "took VAXCHORA without buffer". The patient was receiving oral VAXCHORA for an unknown indication. It was reported that the patient took VAXCHORA in water, without the buffer. The action taken with VIVOTIF with respect to the event "took VAXCHORA without buffer" was not applicable. The clinical outcome of the event "took VAXCHORA without buffer" was unknown. Company's comment: The causality of the event "took VAXCHORA without buffer" was considered as not applicable. Reporter's Comments: The causality of the event "took VAXCHORA without buffer" was considered as not applicable. Sender's Comments: The causality of the event "took VAXCHORA without buffer" was considered as not applicable.
This spontaneous report was received from a health professional refers to unspecified patients of unknown demographics. On unspecified dates these patients were administered with unspecified doses of ROTATEQ (lot # and expiry date unspecified ) which was improperly stored throughout March 2015. No adverse effects were reported. Outcome of the event was unknown. Reporting health professional considered the event to be not related to ROTATEQ. This is one of several reports from the same reporter (MARRS # 1503USA013938, MARRS # 1503USA014260, MARRS # 1503USA014261, MARRS # 1503USA014263, MARRS # 1503USA014264 and MARRS # 1503USA014265). Additional information has been requested.
Severe rash/hives, extreme itching on inside lower arm, and across belly.  Used anti-itch cream, Benadryl, alcohol, and ammonia.   Lasted over a week.
Patient died on 4/5. He experienced diarrhea, nausea and vomiting and then suffered a heart attack.
Pt. reported to pharmacy on 10/11/12 with redness and mild swelling on right arm extending from tricep to bicep.
Information has been received from a female healthcare professional who reports that she had a small amount of Gardasil spray into her eye because of a defective, third party plastic syringe. No symptoms were reported. The Service Request Number is 1-2360217272. Follow-up information received from NSC call (07-FEB-2008): Per the reporter, the Gardasil involved in this case was being administered to a patient. The patient received approximately 3/4 of the dose. No symptoms were reported. Names/initials of the patient were not provided. This was dose 3 for the patient. This situation occurred on 05-FEB-2008 and there are no other details. Additional information is not expected.
2 weeks after vaccination. Extreme fatigue, wt loss (11 lbs in 1 month). Tingling under (L) eye in pain bone. Extreme sweating. Symptoms are still persisting.
2 and 4 month immunization. 8-24-06 and 10-19-06.
Sore Arm; Swollen arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pain in arm and swelling arm. On an unknown date, the outcome of the pain in arm and swelling arm were unknown.   It was unknown if the reporter considered the pain in arm and swelling arm to be related to Flu vaccine.  Additional information received were as follows: The age at vaccination was not reported. The patient stated she experiences slight sore and swollen arm when received flu shot. For tolerance of Shingrix, refer case US2019146715. This case has been linked with US2019AMR147479, reported by the same reporter.
Body ache c/o generalized weakness chills, low grade temp (100.8 in office) decreased appetite.
Right deltoid 5cm x 5 1/2cm rounded firm erythema, slightly tender.
Information has been received from a certified medical assistant (CMA) concerning a 13-month-old white female with no medical history or allergies who on 09-SEP-2005, was vaccinated in the left leg with the first 0.5 mL dose of varicella virus vaccine live (Lot #650222/0425R). Concomitant vaccinations on that same day included a 0.5 mL dose in the right leg of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot #648665/0993P). The CMA reported that on 18-SEP-2005, the patient developed a rash over her entire body except for her mouth and eyes. On 20-SEP-2005, the patient presented to the physician's office with chickenpox characterized by about 50 red spots all over her body. The patient was noted to be afebrile and no laboratory/diagnostic tests were performed. The patient was treated with hydroxyzine HCl (ATARAX) and cephalexin (KEFLEX). In September 2005, a few days after onset, the patient's chickenpox resolved. Additional information is not expected.
Client felt faint and dizzy two minutes after receiving the dose of Janssen vaccine. Client reports no allergies. Client was seated in a chair, and EMTs were called. EMTs assessed the client. Client continued to feel poorly: faint, dizzy, sweaty and pale. Left client in the care of the EMTs.
Patient developed right facial numbness and facial droop on 1/7/21. She came to the TMH ED and was admitted. She was afebrile; neurologic exam was consistent with a peripheral facial palsy on the right.
I was dizzy, weak and nauseous. It felt as if I was going to vomit and then I went unconscious. My husband saw that I had collapsed back into the bed I was leaning against, with my eyes rolled back and I was making a gurgling sound. He attempted to get my attention several ways by loud yelling of my name and lightly hitting my cheek. I was unconscious for a few minutes and when I regained consciousness I had had broken into a heavy, soaking sweat. He described it as looking as if i had a seizure.  I have no history of seizures and have never had one prior to this event and vaccine.