chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she had an enlarged heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), in Jan2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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 (Basically the last Vaccine I have had before Jan2022 was Sep2021), administration date: Sep2021, for COVID-19 Immunization. The following information was reported: CARDIOMEGALY (non-serious) with onset 2022, outcome "unknown", described as "she had an enlarged heart". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter asked for information if one of the side effect of the Pfizer COVID Vaccine was enlarge heart. So, she asked if that was just for the younger ones or if that occurs in adult. It was reported that after she received the vaccine, In Jan2022 she had an enlarged heart and then she mentions that on Jul the same test was done but enlarged heart didn't show. Basically the last Vaccine I have had before Jan2022 was Sep2021 but in Jan the patient had an echo cardiogram, that's where they saw quite enlargement of left ventricle and in July when the patient went for another echo cardiogram they said well it doesn't matter, it's not there anymore.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Severe dermatologic reaction with systemic illness and elevated LFT's and Heme finding post booster.  9/15 - Lesions on foot & hands, mild malaise, chills, (-) fever, LFT's rising - held Rybelsus, start Glyburide Continue ceterzine and advil 9/19 - Progressive lesions and pain on feet, hand, and now face (-) oral lesions or optho lesions Repeat CBC and LFT labs, rx pain med 9/22 - Pain gone, lesions lessened, fingers sensitive 9/24 - No systemic illness, skin resolving 9/28 - No systemic sx at all.  No fever, chills, abd pain, nausea, cp, diarrehea. Notes skin is sloughing with new skin looking healthy- slightly sensitive. Overall, recovering.
SWELLING OF FEET AND LEFT EYE.  HIVES AROUND RIGHT EYE, LEFT FOREARM, AND LEFT JAW.   PATIENT HAS BEEN TAKING BENADRYL AND USING A COLD COMPRESS.  SYMPTOMS HAVEN'T RESOLVED, BUT HAVE REMAINED STEADY WITHOUT WORSENING.  PATIENT REPORTS NOT HAVING A PCP.  I ADVICED HER TO AT LEAST GO TO URGENT CARE FOR A CHECK-UP FOR HELP RESOLVING REACTION.
The rash is located primarily on the right arm.  Rash is described as red.  Associated symptoms include low-grade fever of 100.1.  The rash started approximately 5 days before this visit.  Received shingles vaccine on 02/07/2023. Reports soreness on her right arm. Taking Tylenol now. Had negative COVID. Got headache and low grade fever and arm pain the day after her shot. Diagnosed as local reaction to Shingrix vaccine, possible cellulitis. Was prescribed doxycyline and celebrex.
Ongoing dizziness, vertigo, joint aches, numbness in hands, eye twitching, muscle twitching, palpatations headaches
Patient off ladder on day of admission sustaining a left hip fracture.  Admitted for management. optimized medically and taken to the operating room where patient underwent a left hip bipolar hemiarthroplasty for fracture. Patient tolerated the procedure well with no apparent complications. Patient was transferred to the floor where patient remained afebrile with stable vitals signs.  ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Initial unsolicited report received from a nurse on 18 September 2015. This case involves a 48-year-old female patient who was vaccinated with a first dose of FLUZONE QIV (batch number: UI187AA, expiration date: 30 June 2015, dose and site of administration were not reported) intramuscularly on 31 October 2014. The patient had a medical history of hypertension, gastroeosophagal reflux disease (GERD) Chronic renal, and allergy to Calcium, eggs, bee stings, latex, shell fish, antibiotics. Illness at time of vaccination was none reported. The patient did not receive any other vaccinations within four weeks of vaccinations. On 31 October 2014, immediately following the vaccination, the patient developed dizziness, bad taste in her mouth, blood pressure of 200/104, and swelling. The patient required ER or doctor visit. Lab data was not reported. The patient received Solumedrol intramuscularly as a corrective treatment. The patient was recovered on an unspecified date. List of documents held by sender: none.
Almost had a fever; Felt fatigued; low energy; His left Arm was painful and it got swollen a bit; Unspecified arm painful; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was tested positive for COVID on 21Dec2020. One after that on 20Jan2021, they came up negative. The patient's concomitant medications were not reported. On 20Mar2021 the patient experienced arm pain/Unspecified arm painful and on 21Mar2021 said he almost had a fever and felt fatigued. The same date they took shot is when the arm pain started and on 21Mar0221 the low energy was the day after. On 201Mar2021 His left Arm was painful and it got swollen a bit and lasted for a little longer than 48 hours.  The patient underwent lab tests and procedures which included covid-19: positive on 21Dec2020, covid-19: negative on 20Jan2021. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021433164 same reporter/drug, similar event, different patient
heavy hair loss; loss of appetite; feeling cold; : Caller reported that since last fall she started to present very dry skin in her arms and legs with wrinkling in the back of her thighs as if she was "90-year-old" and not 70; : Caller reported that since last fall she started to present very dry skin in her arms and legs with wrinkling in the back of her thighs as if she was "90-year-old" and not 70; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (COMIRNATY), administration date 06Oct2021 (Lot number: FL3209) as dose 3 (booster), single, administration date 23Jun2021 (Lot number: EW0178) as dose 1, single and administration date 14Jul2021 (Lot number: FA6780) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergy: chicken" (unspecified if ongoing), notes: Caller stated she does not want to eat chicken, meat nor fish; "Known allergy: meat" (unspecified if ongoing), notes: Caller stated she does not want to eat chicken, meat nor fish; "Known allergy: fish" (unspecified if ongoing), notes: Caller stated she does not want to eat chicken, meat nor fish; "hair loss" (unspecified if ongoing), notes: Caller reported that the heavy hair loss began last summer and it is still continuing today. Concomitant medication(s) included: TOPROL XL, start date: 01Jan2021. The following information was reported: ALOPECIA (non-serious) with onset 2021, outcome "not recovered", described as "heavy hair loss"; DECREASED APPETITE (non-serious) with onset 2021, outcome "not recovered", described as "loss of appetite"; FEELING COLD (non-serious) with onset 2021, outcome "not recovered", described as "feeling cold"; DRY SKIN (non-serious), SKIN WRINKLING (non-serious) all with onset 2021, outcome "unknown" and all described as ": Caller reported that since last fall she started to present very dry skin in her arms and legs with wrinkling in the back of her thighs as if she was "90-year-old" and not 70".  Additional information: Caller reported she has been experiencing heavy hair loss since the last summer and it is still continuing today. Caller mentioned that last summer she talked with an Internist from Primary Care about the loss of appetite and she was very concerned about it but has not connected with her since then Caller ask for further information. Caller stated she does not want to eat chicken, meat nor fish and that it not normal on her; then, last fall she started to present very dry skin in her arms and legs with wrinkling in the back of her thighs as if she was "90 years old" and not 70.  No follow-up attempts are possible. No further information is expected.
One of them can't even use the left side of her face; This is a spontaneous report from a non-contactable consumer. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced can't even use the left side of her face. Reporter stated that she had friends who had suffered because of this vaccine. They have had major complications. One of them can't even use the left side of her face and the other one lost her baby. She lost her baby. The doctors say that can't prove it was from the vaccine but they say they are pretty darn sure it is because of the vaccine. The outcome of the event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
had a few welts on my left arm where the vaccine was administered; Entire body was broken out in a rash/on my entire body head-to-toe/The rash is very itchy and sometimes oozes clear liquid; Entire body was broken out in a rash/on my entire body head-to-toe/The rash is very itchy and sometimes oozes clear liquid; Entire body was broken out in a rash/on my entire body head-to-toe/The rash is very itchy and sometimes oozes clear liquid; This is a spontaneous report from a contactable consumer (patient). A 27-year-old-female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6203) via an unspecified route of administration, administered on the left arm on 25Feb2021 14:15 as 1st dose, single for COVID-19 immunization. Medical history included eczema an Allergy to Propylene Glycol. Concomitant medication included birth control pills. After receiving the first dose of the vaccine, patient had a few welts on her left arm where the vaccine was administered about an hour after the vaccine on 25Feb2021. About 3-4 days later (Feb2021), she noticed my entire body was broken out in a rash. The rash was very itchy and sometimes oozes clear liquid. She used steroid cream, creams, allergy medication, but the rash has not went down. It was on her entire body head-to-toe and has been here for 2 and 1/2 weeks with no sign of improvement. No treatment was received. Patient was not pregnant at the time of vaccination. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.
Initial and follow-up information has been received from a physician and a licensed vocational nurse (LVN), for GARDASIL, a pregnancy registry product, concerning a female baby. A 19 year old female on 26-SEP-2007, was vaccinated with her first dose of GARDASIL (Lot # 0530U). The patient's last menstrual period (LMP) was 02-OCT-2007, with an estimated delivery date of 09-JUL-2008. On 02-JUL-2008, 39 weeks from LMP, the patient delivered a normal female infant with apgar score 9/9, weight 3,062 grams. Pediatric medical records were received and reviewed and the following experiences were identified: On 07-JUL-2008 the baby was seen for well child visit. The weight was 6lbs 7.4 ozs, height 18.75 in, temperature 98.5, pulse 146, and respiration 30. The baby had total bilirubin (TBIL) of 17.09 mg/dL. The baby had unspecified neonatal jaundice. On 09-JUL-2008 a family history of alcohol problem, epilepsy, seizure (father), and tobacco use and high blood pressure (maternal grandfather) was noted. On 14-JUL-2008 the baby underwent an upper gastrointestinal (GI) series indicated for gastroesophageal reflux disease (GERD), and persistent emesis. Fluoroscopic evaluation of the upper GI tract was performed with multiple spot films. Impression was gastroesophageal reflux, nasopharyngeal reflux noted as well. There was no evidence of pyloric stenosis or small bowel malrotation. On 16-JUL_2008 the patient had a 2 week well child visit and recheck of GERD, status post UGI. Feeding difficulties including spitting up while feeding. Weight: 6lbs 14.08 oz, height: 19 inches, temperature: 98.5, pulse: 132, respiration: 34. A recheck total bilirubin was 10.94 mg/dL. Physical exam showed skin with slight jaundice. Assessment was unspecified neonatal jaundice, GERD and constipation. On 29-JUL-2008, at 3 weeks old, the baby was seen by the physician and presented with complaint of GERD. The physician's assessment indicated that the baby was doing well on Enfamil AR and no longer jaundiced. Weight was 8lbs 4.96 ozs. Temperature: 98/3, pulse: 128, respirations: 26. Assessment was GERD. This is an amended report. The baby's birth weight now reads 3,062 grams instead of 3.062 grams. The mother's experience has been captured in WAES0711USA06548. Additional information is not expected.
Patient presented to Hospital Center after what appeared to be a seizure /status epilepticus on 9/17.  He did have a fever shortly after arrival and had a negative work up for meningitis.  He was admitted to the hospital for 5 days.  He seems to have fully recovered.
Heaviness in limbs, extreme weakness and fatigue, worsening of neuropathy symptoms, trouble breathing,
stroke-like symptom; Left arm droop; no feeling on left side; loss of mobility in left arm; droop on left side of face; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: Ek4176) via an unspecified route of administration on 16Jan2021 at 10:00 AM at a single dose for COVID-19 immunization. Medical history included blood pressure needs controlling and allergies: penicillin. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included nebivolol hydrochloride (BYSTOLIC), terazosin, famotidine, olmesartan (reported as olmsartan), amlodipine, and atorvastatin calcium (ATORVASTIN). Facility where the most recent COVID-19 vaccine was administered at nursing home/senior living facility. The patient was not pregnant at the time of vaccination. On Tuesday 19Jan2021 at 5 am, patient had stroke-like symptom: left arm droop, no feeling on left side, loss of mobility in left arm, droop on left side of face. The event resulted in emergency room/department or urgent care, and hospitalization. The event was reported as serious with seriousness criteria of caused/prolonged hospitalization. It was unknown if treatment received for event. The outcome of event was unknown. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
2 month old pt here for routine check up, physical exam entirely normal. Pediarix, Hib, and Prevnar administered: Baby immediately turned bright red. Spina Papules or hives.  Child spontaneously recovered.
Narrative:  Fully vaccinated, admitted for worsening L foot wound, received amputation and found to be COVID positive
Patient complained of itching and pain after administration. 1 months post vaccination, patient is still suffering from pain. She is awaken at night from the pain and is unable to fully move arm. She complains that it is difficult to exercise. She has been advised by her physician to take ibuprofen.
About 10 minutes after vaccination- developed numbness on left side of face. Resolved within 15 minutes. Intermittent over next 2 months. On Jan 12- noted new lymphadenopathy left supraclavicular region into left axillary. On Jan 16- left hand became dusky/ blue- seen in ED.  Abnormal Allen?s test, CTA left arm no occlusion. New diagnosis HTN and EKG with intermittent a fib/ a flutter. Subsequently seen by PCP (new HTN), Vascular (tests normal), Neuro (left arm EMG) and cards EP (28 day monitor pending). Symptoms of left face numbness and arm numbness persisted through January. Resolved by mid Feb. in addition, was started on HCTZ for HTN  with new SBP max 160s and DBP 100s. By March, SBP down to 100s and HCTZ stopped. BP since normal. No recurrence of face or arm numbness. Persistent left supraclavicular LAD , although decreased since January.
DVT, placed on Lovenox, pt back to ER for bursitis of R knee on 07/30/2021
Information has been received from a registered nurse concerning a 12 month old white female with no pertinent medical history, drug reactions or allergies who on 03-DEC-2007 was vaccinated with ZOSTAVAX (Oka/Merck) (Lot # 658603/1081U) instead of varicella virus vaccine live (Oka/Merck). The nurse noted the medication error occurred due to the fact that the two vaccines were in the same freezer in side by side labeled bins. It was further noted that the vaccine bins have since been moved apart and the bins have been labeled clearly with different colors. Vaccine therapy that same day included MMR II (Lot # "0413U"), Hib conj vaccine (unspecified carrier) (ACTHIB) (Sanofi) (Lot# UF196AA), TRIPEDIA (Sanofi) (Lot # C2651AA), PREVNAR (Lot # B08702A), and HAVRIX (GSK) (Lot # AHAVB181AA). On 05-DEC-2007 the patient developed a temperature of 100-101F, which lasted one day. It was also noted that ( post vaccination) the patient was "fussy" more than usual for a period of three weeks, which resolved on 24 DEC 2007. There was no reported illness at the time of vaccinations. There were no reported adverse events following prior vaccinations. There were no concomitant medications. Medical attention was not sought. There was no product quality complaint. There were no lab diagnostic studies performed. No further information is expected.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not known. On an unknown date, the patient was vaccinated with GARDASIL at the age of 11 years, 12 years and 13 years with the first, second and third dose respectively via the intramuscular route. The patient also received a fourth dose of either GARDASIL 9 or GARDASIL (unspecified Merck HPV vaccine). No adverse effects were reported. Additional information has been requested.
Fever of as high as 102 degree Fahrenheit and intermittent headache. These symptoms have existed since they first appeared. They have not receded as of Saturday 12 pm.
I felt foggy and disoriented and tired within a half hour of receiving the vaccine.   I felt pain in my arm traveling to my underarm.  After an hour I felt like the inside of my skin was prickly and tingly, my face was flushed and burning.  I was so tired I had to lay down.  I just stared into space.  There was ringing in my ears.  My heart rate was a good 20 beats per minute faster than normal.  By bedtime, my face was slightly swollen and I was unable to read because the letters were jiggly.  I had a traveling headache from the side to the top of my head through my eyes.  My breathing was more rapid and shallow.  I felt intermittent chest tightness. And pain.  The next morning, I felt better, but the prickly skin continued and my chest and back were  sore.  I had intermittent cramping in my feet and was sore in my joints.  My arm was very tender.  I was still tired and my heart rate was still elevated.  I did not sleep well and got up frequently during the night to walk around.  By the third day the prickly skin was almost gone, but I have had cramping in my chest and feet.  I am very tired.  I still have an occasional traveling headache.
Received Moderna COVID #2 early.   Patient was scheduled to return on 5/11.  however, presented to vaccination site on 5/1 and received dose #2.  Verified with CDC, dose #2 is considered valid.
weakness; like she has weights on her legs and arms; Headache; tiny bit of a sore arm; This is a spontaneous report from a contactable consumer o(patient herself). A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6198), via an unspecified route of administration in left arm on 17Feb2021 13:40 as dose 2, single for COVID-19 immunisation (at the age of 73-year-old). Medical history included redundant colon, IBS C, a little elevated cholesterol, arthritis, right hip replacement, Epstein bar virus in 199, vitamin b12 deficiency (in college), low estrogen and progesterone (in the early 2000s) and mother had Alzheimer's and died at 81 and her father they think it was mesothelioma. There were no concomitant medications. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EL3246), via an unspecified route of administration and location on 27Jan2021 as dose 1, single for COVID-19 immunization (at the age of 73-year-old). On 17Feb2021 21:00, the patient experienced headache. On 07Aug2021, started having extreme weakness. The weakness is not fatigue, it feels like she has weights on her legs and arms. The patient had this weakness three other times in her life but every time they found the cause of it one time the caller had the Epstein bar virus in 199. The patient's B12 was fine, and it showed that she had Epstein Bar but they did a titer and checked to see if she had a current infection and it came back negative. Since the caller's weak she is not doing a lot and her Gynaecologist said the more she is not active the worse the weakness will be. On an unspecified date, the patient experienced tiny bit of a sore arm. The caller has been trying to push herself, but she was so weak she had to lean on a cart to get through the store. The caller had a physical and blood work, and it is perfect and there is no reason for this. On 13Aug2021, the patient underwent lab tests and procedures which included blood work: came back perfect. On 07Sep2021, CT abdomen: normal. On an unspecified date, Epstein-bar virus test: nothing has come back, Lyme's disease: nothing has come back, checked for vitamin deficiencies: nothing has come back and mammogram: normal. The outcome of the event tiny bit of a sore arm was recovered and all other events was unknown.   Follow-up (08Sep2021): This is a follow-up spontaneous report from a contactable consumer it included: event information updated, medical history and other clinical course has been updated.
After the booster, injection site was sore and became very itchy on the 2nd day.  About 6-7 days after the shot, I developed an itchy rash on both forearms, then on both calves, then on right underarm and chest area, and yesterday (9 days after shot) on neck and throat area, including jawline and lower cheeks.  The rash is very red and bumpy and is very itchy from time to time.
At about 10pm on 04/20/2021 My body was aching. I woke up at 6 and developed severe chills, headache and vomiting. This lasted until 9PM that evening of 04/21/2021. Shortly after, I developed lymph nodes around my collarbone on my left side. It was painful for about a week.
Severe headache, body aches, chills (got hot then cold). Also, could not sleep during these symptoms.