chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The caller is feeling a tingling in the body.; The caller states the tingling is over the legs, felt in the head and arms, little sensations; This is a spontaneous report from a contactable 48-year-old female consumer reported for herself. A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 30Jul2021, it was afternoon, after 17:00 (at the age of 48 years old) as single for covid-19 immunisation. Medical history included Pre-diabetic from 27Jul2021 and ongoing, high blood sugar from 27Jul2021 and ongoing. She had blood work done on 27Jul2021, three days prior to receiving the first dose Pfizer Covid Vaccine. The blood work reported the caller had high blood sugar and was pre-diabetic. There were no concomitant medications. She was a consumer calling to report side effects from the Pfizer Covid 19 Vaccine. On 01Aug2021 patient experienced feeling a tingling in the body. She stated she had one of the unusual side effects and its been like a week and a half ago the she received the first dose Pfizer Covid 19 Vaccine. She was feeling a tingling in the body. She stated the tingling was over the legs, felt in the head and arms, little sensations. She stated this began 01Aug2021, two days after receiving the first dose Pfizer Covid 19 Vaccine. She was still feeling little things but not as much as before. She stated she has only received one dose Pfizer Covid Vaccine and was scheduled to receive the second dose Pfizer Covid Vaccine. The patient did visit physician office. She stated she did not go to the emergency room and she stated she called her doctor's office. The outcome of events was recovering.  Follow-up activities closed. Batch/lot number not available for [Vaccine BNT162B2].
Pt recvd 3 doses of Engerix-B on 17JUL90; 17AUG90 & 24JAN91; pt did not convert positive for HBSAB; no tx given;
NUMBNESS/REDNESS/TENDERNESS WARM & PAIN AT INJECTION SITE Narrative:
CROHN'S ILEITIS; This spontaneous report received from a patient via other manufacturer concerned a 7 decade old female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: colectomy total (whole large intestine removed in 2003), and concurrent conditions included: moderate to severe adult Crohn's disease, and Crohn's ileitis (Crohn's disease appeared in small intestine from 2007). The patient initially received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total (first dose) administered on 15-APR-2021 (1 in 1 once) for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 65 years old. No concomitant medications were reported.  Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1161452, expiry: unknown) dose, frequency, and therapy dates were not reported for moderate to severe adult Crohn's disease.  On an unspecified date, the patient had Crohn's disease appeared in small intestine (Crohn's ileitis). Patient was trying to control with Humira. She had bag. She had to change it more often and had bad cramps at times. Humira had slowed the Crohn's in small intestine. She had pain and was unable to put on weight (weight gain poor) (dose number in series 1).  The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total (second dose) administered on 14-JAN-2022 (1 in 1 once) for covid-19 prophylaxis. It was unknown if patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2). The patient additionally received Moderna covid-19 vaccine (Elasomeran) (dose number in series 3) (form of admin not reported, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, (booster dose) administered on 30-JUN-2022 (1 in 1 once) for covid-19 prophylaxis. It was unknown if patient had any adverse events following vaccination with Moderna covid-19 vaccine (Elasomeran) (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of adalimumab was not changed. The patient was recovering from Crohn's ileitis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220812114-covid-19 vaccine ad26.cov2.s-Crohn's Ileitis. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Loss of appetite, leading to weakness, dehydration, kidney issues, and anemia, along with diarrhea/constipation, right leg circulation issues
On the evening of Sunday December 27th I became violently ill.  I began vomiting and continued all night long.  I had severe body aches and chills.  I was unable to find my thermometer so am not sure of tempertature.  I had lower back pain so severe I couldn't lie down.  I tried to take Tylenol but was unable to keep it down.  By morning  I got access to Tylenol suppositories,  Dramamine, and a thermometer.  My temperature before Tylenol was 104.4.  These symptoms continued over the next 3 days though vastly improved with Tylenol, Dramamine and IV fluids.  I received a negative COVID test on Thursday.  I have only been this ill once before in my life.  By Thursday I was not longer febrile, only weak and exhausted.  I have to now determine whether or not to get the second vaccination.   I know  this seems to be a somewhat delayed reaction.  Any advice would be appreciated.
Employee received vaccine on 12/21/12; on 12/22/12 began to experience weakness and pain in the (L) arm. Noted swelling at injection site which has since disappeared, but pain in the (L) arm persists. No loss of mobility reported. Has not sought medical attention.
Patient seen in office on 2/6/08 for red bump on leg, r/o reaction to shots. On 1/25/08, pt received Hep A and Varicella in right leg. MD noted area on right lateral thigh 2x4 cm, red, warm, indurated, nonfluctuant area of cellulitis. MD rxed Keflex 250mg TID x10 days.
This spontaneous report as received from a physician via company representative refers to a 63 year old female patient. The patient's medical history included previous history of atrial fibrillation (AFIB). On 31-DEC-2013, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml injection once shot (route, lot# and expiration date unspecified). Concomitant therapies included BETAPACE 80 mg, two times a day and aspirin. On 31-DEC-2013, according to the physician, a patient went into "atrial fibrillation (AFIB)" 10 minutes after being administered ZOSTAVAX at a pharmacy. It was stated that this symptom lasted for "about 12 hours." Patient did not seek the medical attention, no laboratory test were performed, no treatment was given. The relatedness between event and ZOSTAVAX was not reported. Additional information has been requested.
The solicited report was received from a physician referring to a 62 years old female patient enrolled in a marketing research program. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date in 2015, the patient was vaccinated with her first dose of ZOSTAVAX, one time injection (route of administration, lot# and expiry date were not reported). On an unknown date in March 2016, the patient went down with "mild case" of shingles that lasted approximately 3 days after receiving the ZOSTAVAX. The patient recovered with sequelae from the event on an unknown date, 3 days after the onset of shingles. Causality assessment was not provided. This is one of several cases from the same reporter. Additional information is not expected, as there was no consent for follow up.
PATIENT REPORTED REDNESS AT INJECTION SITE, SWELLING, ITCHING. AREA IS WARM TO THE TOUCH . COMPLAINS OF PAIN REACHING UP TOWARDS HER NECK
Initial unsolicited report received from a pharmacist on 01 September 2015. This case involves a patient (age and gender not reported) who was vaccinated with a high dose of FLUZONE HD (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date following the vaccination, the patient experienced potential problem with high dose of FLUZONE. Laboratory investigation and corrective treatment were not reported. The patient's outcome was not reported. Documents held by sender: none.
Tinnitus both ears started a few days after 2d Pfizer covid dose on March 31. Consulted Doctor April 15. Had ear wax removed from 1 ear April 20.  Tinnitus has continued.
Rash on my neck and my head and my shoulders; This is a spontaneous report from a contactable consumer (patient). A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 06May2021 11:15 am (Lot Number: EW0182; Expiration Date: Aug2021) as UNKNOWN, SINGLE for covid-19 immunisation. Medical history included mouth surgery. Concomitant medication included omeprazole (PRILOSEC [OMEPRAZOLE]) taken for an unspecified indication, start and stop date were not reported. The patient stated "I had the Pfizer shot (Covid-19 Shot) yesterday at 11 o'clock (06May2021) and then I woke up this morning with a rash on my neck and my head and my shoulders (on 07May2021). So, I was wondering if that is something that I need to go to (sentence incomplete), I tried to take a Benadryl, but it didn't help. So, is it something that is going to pass?". Patient stated "I got the shot at 11 o' clock like 11.15 in the morning and then I started feeling it about 5:00 or 6:00." Therapeutic measures were taken as a result of the event. The outcome of the event was not recovered.  Information about lot/batch number has been requested.
Pain and discomfort in left arm and upper left back, continuous.  minor relief from heating pad.  difficulty sleeping. baclofen 10 mg no effect.
Case number PHEH2013US020748 is an initial spontaneous report received from a consumer (patient) on 03 Oct 2013. This report refers to a 62-year-old male patient. His medical history included leukemia. He was vaccinated with flu vaccine (manufacturer and batch number: unknown) intramuscularly on an unspecified date. He experienced nausea for a couple of after receiving flu vaccine. Outcome, seriousness and causality of the event were not reported.
MOTHER STATES SYMPTOMS STARTED ON THE 15TH OR 16TH.  HE COMPLAINED OF SORE THROAT.  MOTHER STATES HE HAD DIFFICULTY BREATHING, HOARSENESS, WHEEZING, PALENESS, WEAKNESS, A FAST HEART BEAT AND DIZZINESS.  DENIES HIVES.  HE WAS TAKEN TO ER ON 11/19.  SHE SAID HIS HEART RATE IN ER WAS 152 AND HIS BP VERY LOW.  HE WAS DIAGNOSED WITH PNEUMONIA.  HE HAD A RESPIRATORY ARREST AND THEN LATER KIDNEY FAILURE. PARENTS CAME AND REPORTED THIS TO FIRST DISTRICT BECAUSE  THE CLINIC HAD TOLD THEM TO.  THEY WERE RELUCTANT TO GIVE THEIR ADDRESS AND THEIR NAMES.  "WE HAVE BEEN THROUGH ENOUGH."  12/8/06 Received medical records from 1st hospital which reveal patient admitted 11/19/06.  Patient had 4 days of sore throat, fever, dry cough & diarrhea.  Patient continued to deteriorate, coded & expired on 11/22/06.  No autopsy was done. LABS: CXR hazy infiltrates in bilateral lung bases. CT of abdomen & pelvis WNL.  US of kidney was WNL.  CK 11, 046 & troponin 0.24. Bone marrow biopsy done was WNL.  WBC 9.21, plts 99, Na 131, elevated liver enzymes. Final Dx: acute tubular necrosis; chronic renal failure likely secondary to HIV nephropathy; HIV positive; COPD, thrombocytopenia; culture negative sepsis; hypotension; respiratory failure/hypoxia; alcoholism; tobacco abuse; seizures secondary to head trauma; depression; s/p LS operation; hypothyroidism; insomnia; and anxiety. 1/5/07 Received Death Certificate from funeral home which reveals COD as HIV/AIDS with rhabdomyalysis as a contributing factor.
This spontaneous report was received from a 60 years old female physician via a company representative and refers to herself. No relevant medical history of the physician was reported. On an unspecified date in 2012, the physician was vaccinated with ZOSTAVAX (strength, dose, lot number and route of administration were not reported). There were no concomitant medications reported. On an unknown date the physician experienced herpes zoster, after receiving ZOSTAVAX. The physician treated herself with an unspecified medication. There was no product quality complaint involved. The action taken with the ZOSTAVAX was not applicable. The outcome of herpes zoster was reported as recovered on an unspecified date. The causality of the event was reported. Additional information has been requested.
Rash, low grade fever, fatigue, headache loss of appetite.  VARIVAX given 8/17/09.  Symptoms started 1 week later.  Came into clinic.  Quick strep neg.  Given BENADRYL.  Throat CX positive for strep.  Treated with AMOX.
Information has been received from a medical assistant referring to a 15m months old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.On 11-JUN-2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported)(Incorrect product storage). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
A report has been received from a Health Professional concerning a 9 year old, Female subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on an unknown date. It was reported that patient was 9 years old and received the FLUMIST vaccine with the second half of the dose not administered fully into the second nostril which started on 18-Nov-2015. The outcome of the event of INAPPROPRIATE ADMINISTRATION was unknown. The report was considered to be non-serious.
Sore arm, headache and redness  (particularly left beast) itching and felling as though my skin is hot.  Mostly upper body.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Clinic consulted with the department of health and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Clinic is working with the health department on a compliance improvement plan and has been reinstated vaccination privileges.
She came in and showed me a 3 to 4 inch in diameter bright red circular injection site reaction.  She stated it was itchy and somewhat hot. It was 3 days post vaccination. Was given 06/16 patient did not report until 06/19. Recommended patient to call MD, take BENADRYL and place ice pack on arm. I tried calling patient provider but they are only open on Thursday and Fridays (left message).
hearing loss; This is a spontaneous report from a contactable Pharmacist.   A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced hearing loss on an unspecified date after the first dose in one of his ears. Outcome of the event was not recovered.    Information on lot number/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of hearing loss due to temporal relationship.  Case will be re-assessed upon the additional information provided.
After I received the vaccine my arm hurt and I felt run down for 2 days. But now 8 days later my arm hurts again like I just got vaccinated and I feel run down. Not a huge deal, but just want others to know to expect something like this.
Huge red spot at injection site - approx 10cm in diameter. Itchiness at red spot. Overwhelming fatigue that required time off work
Information has been received from a certificated medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored PROQUAD (lot # M004894, expiration date 26-JUL-2017, lot # M011661, expiration date 08-SEP-2017, lot # M017334, expiration date 05-OCT-2017; dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I've had a couple of things come up and I don't think they are necessarily related but I had an episode Grady cardia (slow heart rate) my heart rate dropped down to the 30's and was persistently low for 24hours. I'm waiting for a Cardiologist for the follow-up. They also found I have a intussusception and they discovered a venous malformation in my neck. I went to the ER and that's how they found the intestinal issue.
Reports feeling pain in the right arm involve both the upper arm and the forearm. Took the vaccine in right upper arm 2-3 weeks ago.
swelling of arm at injection site, redness, tenderness, discomfort itching, fever
Sore throat, fever, severely dizzy, severe headache (mostly migraine), chills, fatigue.
Extreme muscle and joint pain, headache, dizziness, diarrhea, fever, fatigue, loss of appetite, film on tongue
Patient developed injection site reaction at the right deltoid where immunization was given. It swelled up and was warm and itchy, patient went to a physician to get it examined.
Started next morning with headache, body aches, joint pain (all over).  Fatigue.  Later in evening, stomach pain, and other symptoms mentioned.   I took acetaminiphin with little comfort.  Today, D+2 still have some fatigue and site soreness but major symptoms gone.
Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area; extremities)Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Feeling warm-Medium.
Nausea, irratio heart beat, headache, sweating lasting 2 days.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 via a home test on 09/06/2022. I had a fever, nasal drip and a cough. I had a telehealth visit with my doctor and was prescribed Paxlovid. I'm not sure the Paxlovid really helped but I felt better with a week. I continue to have a cough and I'm tired.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 12-SEP-2013, the patient was vaccinated with ZOSTAVAX (lot # J002777 and expiry date 07-JUN-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would had been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different Lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX Lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to on an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his records didn't indicate when he received each Lot but he was calling further for the data. He also could not identify, at this time, which Lot# was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of the ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
On right deltoid after yellow fever yellow fever injection pt has had a small splotch of redness appeared around injection site. The redness was gone in a matter of a couple hours.
Patient wa receiving their first Pfizer COVID vaccine.  Student was well hydrated and had eaten a meal prior to vaccination.  After administering vaccine, patient lost consciousness, slumped to her left side, and had seizure-like body jerk movements.  She then regained consciousness, then lost consciousness again immediately after and proceeded to have whole body jerking movements.  She then started sliding to the floor from her seat.  Patient was lowered to ground with help from another RN.  Vitals were taken, BP 102/82, HR 48 and RR 20.  Dr. assessed patient and 911 was called for further assessment.  Patient was not transported in ambulance and left clinic with parent recovered.
Right arm reddened, warm, indurated deltoid area.  Area of redness 17cm X 17cm.  Also with fever and chills.
Patient was administered tetanus toxoid vaccine on 9/28/09 and developed localized edema and swelling after receiving injection.  No nausea, vomiting, or shortness of breath was noted.
I tested positive for COVID-19 12/16/2022. My symptoms were that I had a fever, headaches, scratchy throat, cough and overall achiness. I did not have difficulty breathing. I took received Paxlovid medication. I have a little bit of residual cough still today and slight bit of tiredness. I also took Tylenol and Ibuprofen as pain medication. I tested for COVID-19 today and showed very slight line.
This spontaneous report as received from a licensed practical nurse refers to unspecified number of patients with unknown demographics. On an unknown date, the patients were vaccinated with a dose of ZOSTAVAX (Lot number, expiry date, route and dose were not reported). On an unknown date, the patients experienced swelling at the injection site after receiving ZOSTAVAX. The outcome of swelling at the injection site was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
SWOLLEN, RED WELT LOCATED ON BACK OF LEFT ARM TRICEP. PT SEEN BY PROVIDER ON 12/16/14 AND DIAGNOSED AS LOCAL ALLERGIC REACTION.