chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lung infection; felt sick; This is a solicited report from a non-Pfizer sponsored program FACILITATED COLLECT received by Pfizer . A contactable consumer (patient) reported that a 56-year-old female patient received second dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), intramuscular on an unspecified date at single dose for COVID-19 immunisation, upadacitinib(RINVOQ) oral from an unspecified date at an unspecified dose and frequency for moderate to severe rheumatoid arthritis. The medical history and concomitant medications were not reported. The Historical Vaccine was first dose BNT162B2 for Covid-19 immunization. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient Took her 2nd COVID-19 vaccine, Pfizer, felt sick since she took it, then went to her primary physician and she has a lung infection and was on a round of 10 days antibiotics. The action taken in response to the event for upadacitinib was unknown. The outcome of the events was unknown. The reporter's causality for the events was not provided.  The reporter's assessment of the causal relationship of the events with the suspect product 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.  No follow-up attempts are possible; information about batch number cannot be obtained.; Sender's Comments: There is a probable causal relationship between BNT162B2 and the event, Pneumonia based on temporal association. The impact of this report on benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Ethic committees, and Investigators, as appropriate.
04-29-03:  Awakened around 4AM with chest pain, heaviness, SOB, elevated heart rate, headache, shaking.  Examined at Center ER.  Admitted.  EKG-normal; all cardiac tests normal.  Discharged home 04-03-03 with diagnosis of possible reflux.
Pt received I.M. injection L deltoid - had immediate itching, swelling, erythema.
My wife and I obtained our son's shot records recently for day care services, and upon further review I noticed he received an Influenza Vaccine on the above date with notations from the medical office that the Vaccine was expired on 6/30/2011. The form states that Dr. was advised, however she did not feel the child was in any danger and the solution should still be good. Since receiving that shot my son has had a rash on his leg that will cause him pain if you touch it too much. When we returned to the doctor, she stated it was probably eczema and provided a lotion to use. We did ask if this was a side effect from the shot, and she stated no. We have been treating this ever since. I am concerned and think this needs to be reported, and dealt with. I am willing to provide any and all documentation needed for this investigation. Thank you in advance for processing our request.
Swollen,red area, size of grapefruit on left arm,  fever, area was tight and red, saw FNP, dx sterile cellulitis, abx rxd, r/t fever, 5/8' needle used for IM injections. I was notified by the pt about the Dr visit and the FNP has called
Severe, profound and permanent pervasive developmental disorder, language delay and autism. Immediately after shot, he started running very high fever, became very quiet and appeared to be confused.
Fever, body aches, severe headaches, the vaccine site is hot and swollen and painful
I had a droop in my right eyebrow. I had pain in my lower right check bone and near my right ear. The pain on my right side subsided after a couple of weeks but it comes back on and off. The droop in my right eyebrow lasted for about a few weeks. I occasionally get a shooting pain through my right cheek bone. I was prescribed anti-inflammatories for the bell's palsy I was diagnosed with.
Blood clot in leg; This is a spontaneous report from a non-contactable consumer reported for himself. A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 01Apr2021 02:00 PM at 42-year-old at single dose for COVID-19 immunisation. Patient had known allergies (unspecified) and other medical history (unspecified). There was no covid prior vaccination. There is no other vaccine in four weeks. Other medications in two weeks included antibiotics. Patient experienced adverse event: blood clot in leg on 03Apr2021 02:00 AM. The adverse event resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Patient received treatment for events included blood thinners. Patient had covid tested post vaccination on 21Apr2021: Nasal Swab: Negative. Patient was not recovered.      No follow-up attempts are possible; information about lot/batch number cannot be obtained.
right side facial pain; Right side jaw pain; Right side facial and arm tingling; Right side lip tingling; Right side of facial and arm numbness; Right side of lip numbness; fever 101-102+; arm pain; body aches; headache; nausea; chills; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 6206), via an unspecified route of administration in the left arm on 15Mar2021 at 14:30 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included pituitary adenoma. She was allergic to sulfa and codeine. Concomitant medications included Loestrin w Iron BC and cabergoline (MANUFACTURER UNKNOWN) taking for unknown indications and were received within 2 weeks of vaccination. The patient previously received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration in the left arm on 22Feb2021 at 14:30 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. She did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, she was not diagnosed with COVID-19. Since the vaccination, she had not been tested positive for COVID-19. On 16Mar2021, at 03:00, the patient experienced fever of 101-102 plus, arm pain, body aches, headache, nausea, and chills. On 16Mar2021, at 16:00 she took tylenol, one every 4 hours for 3 days as a treatment and most of the events were recovered by 17:00 to 18:00 on 16Mar2021. After 72 hours on 18Mar2021, she had experienced right side facial/jaw pain, right side facial/lip and arm tingling along with numbness and these reactions continued on-off all day, and were ongoing at the time of report. The patient did not receive any treatment for the events. The clinical outcome of the events fever, arm pain, body aches, headache, nausea, and chills were resolved on 16Mar2021 whereas, the clinical outcome of the events right side facial pain, right side jaw pain, right side facial and arm tingling, right side of facial and arm numbness and right side of lip numbness was unknown.  No follow-up attempts are needed. No further information is expected.
In the Hospital with Atrial fibrilation; This case was reported by a consumer via interactive digital media and described the occurrence of atrial fibrillation in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 4 hrs after receiving Shingles vaccine, the patient experienced atrial fibrillation (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the atrial fibrillation was unknown.   It was unknown if the reporter considered the atrial fibrillation to be related to Shingles vaccine.     Additional Information: GSK receipt date: 18-FEB-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient took the shot and four hours later in hospital with atrial fibrillation. The reporter reported that be careful what you put in your body. Additional Supportive Information: The follow-up could not be possible as no contact details were available. Narrative was not clear about the hospital situation it was unknown if patient stayed at least overnight. Since no contact information was available the Hospitalization was selected as a Seriousness criteria.
Pt in for immunizations. Due today for Tdap, Men Quad, and HPV. VIS given to mother before administration. Tdap and Men Quad given in LD, Gardasil given in RD. After completion of administration of vaccines, pt had a near syncopal episode with singular body jerk. No loss of consciousness, no head injury. Pt A&O x 4 immediately following incident and no evidence of post-ictal state. No loss of bowel/bladder control and VS WNL. Pt follows commands and answers questions appropriately. Patient's mother called for assistance and patient was assessed by 3 clinic RNs and clinic supervisor discussed follow up care with mother of patient. Pt's mother verbalized understanding and ambulated with patient to lobby. Patient ambulatory with steady gait, no s/s of distress noted.
Case number PHEH2012US005712 is an initial spontaneous report received from a health care professional on 12 Mar 2012 with a follow up information received on 26 Mar 2012 and a follow up received on 23 Apr 2012. This report refers to a male patient whose age, medical history, past drugs, current conditions and concomitant medications were not specified. His vaccination history included administration of MENACTRA (other manufacturer, batch number: unspecified) on 27 Oct 2008. It was reported that he was vaccinated only with MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: X10062, expiration date: Feb 2013) intramuscularly on to left arm on 06 Feb 2012 and did not receive the MenA lyophilized conjugate vaccine component. No adverse reaction was reported following this administration error. The patient was scheduled for re-vaccination with MENVEO on an unspecified date. Follow up received on 26 Mar 2012: Updated patient demographics (height and weight), vaccination history and vaccination site. Follow up received on 23 Apr 2012: Updated patient demographics (initial), comment on re-vaccination added.
vaccine given 8/3/23 in the morning. On evening of 8/3/23 patient developed nausea with vomiting. On 8/4/23 patient had fatigue, nausea anal diarrhea. He also experienced this on 8/5/23. Symptoms resolved by 8/6/23.
Vasovagal Near Syncope     Lightheadedness, Hypotension, Nausea   Patient is a 45-year-old female with history of hypertension, anxiety. Patient received vaccination at 14: 05, approximately 5 minutes later at 14:10, Vasovagal response
Pt states " shaking, chills and confusion started 2-3 day after injection and last a less than 24 hours.
Right leg, ankle, foot injury and other symptoms. Starting 01.11.2014 Sat, my first adverse reactions were: strong persistent headache, right leg/ankle/foot with pain, swelling, numbness and tingling of same area. Toe area was black and blue - right foot. Starting 01.13.2014 Mon. my lower right leg and foot had the chills. I had a persistent strong headache that lasted the whole week, my vision became painful when I tried to read anything, mild fever, mild bruising, pain, redness/sunburn-like skin of my right foot, numbness, swelling of my right foot and ankles and legs, right foot had gone through some muscle weakness, my right foot-my skin became dry, rough, leathery, and weighed extra heavy while bottom of foot sagged from it's extra weight. My right lower leg and ankle is bent, crooked (moved to one side), and out of joint. I can't walk without assistance (a walker). I experience fatigue, sleep more, lack strength which limits the amount of work that I can do each day. On some days, my feet are very sensitive to any floor surface that I walk on so I may end up taking TYLENOL or aspirin for pain. Frequently, I skip meals because it's too painful/difficult to walk. The pain is not primarily coming from a tingling foot. Mostly, when I's sitting or standing, my right foot will not lay flat on the floor. My arch to my heel wants to stand off the ground. Sometimes, my upper left leg and hip will start hurting because of how much the left side of my body has to support the rest of me. On 01.16.2014 Thu. is when I first got up off my bed to start walking and start my day. I started taking a few short steps passing two lazy boy chairs and near the second chair my right ankle gave way two times within five minutes causing me to slide onto the floor along side the chair and then I had a hard time getting into the chair. The second time I fell my right ankle made a squishy sound. On 01.13.2014 Mon. is when I took my mom to and from a dr's appt., and before we got home we stopped at our local grocery store. My foot was swollen and hurting and as I proceeded to pass (heading to the store) our car, my ankle locked up in intense pain and I had to hop back to the car. I had to do the same thing when we went home (hop). The only shoes I've been able to wear was house shoes. I've had to go from crawling all over the house to using a walker every where I go. I rarely drive a car (now). It's just too hard and scary now. I can only go shop in stores that have the  handicap scooters. My mom pain for my flu shot and a walker for me. I live with her and she supports me. I have no income and no medical insurance. The medical clinic that I'll be going to is a low cost charity clinic. My first dr's visit is on: 04.22.2014 Tue.
This non-serious spontaneous case, initially received from other non-healthcare professional on 13-Nov-2018, concerns a 66-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 Celsius. On 18-Oct-2018, the patient was administered FLUAD (TIV) [batch number: 250795, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805538 was crossed linked to original case 201804863 due to same reporter.
I  felt  poorly in  mid-June  2021 about  5 or 6 weeks after the vaccination,  I remember feeling chest palpitations and racing pulse and cold-like symptoms and went to a local clinic to be  tested for COVID19.  I tested negative for having COVID 19 but had the long term antibodies for it.   I late November 2021, I was having racing pulse (around 1600) several  times throughout the evenings and night and the  triage nurse for my PCP wanted me to  go to the ER.   I went to  a local Hospital  (approximately 12-05-2021) and was  diagnosed with a Left Bundle  Branch Block.   I have  never had  a Left  Bundle Branch Block before and have been told that  this  may have occurred as a result of  taking the J & J vaccination.   I have since seen a private cardiologist at a local office and did a 30 day heart monitor to check for issues such as A-Fib from mid- December 2021 into  January 2022.   I do not yet have  results.  My  appointment with the cardiologist is  scheduled for  February 11, 2022.
08/10/2005 - around 3PM Prevnar 3rd dose.  08/11/2005 around 11AM - facial swelling with whelps and conjunctival swelling.  No shortness of breath, no cough, no new lotions, no meds given, no reaction to 1st and 2nd dose of prevnar.
Pain at injection site. Tingling of fingers. Pt taking APAP. Pt went to MD -> dx hematoma.
About hrs after receiving injection- bad headache started - same as with the first injection. Not debilitating. Then extreme fatigue started, some minor dizziness. Not debilitating. I work in a cardiology office. Administrator advised me not to come in. Ended up sleeping for most of the next 18 hrs.  No nausea, no elevated temp. Just unbelievable fatigue.
Child developed fever, rash, erythema, an was irritable. Seen again with wide spread rash, erythema. He formed no mucous membrane involvement. He was treated with prednisone, there was no other illness. Due to the allergic and prolonged nature of response to vax, recommend no further doses.
covid_test_result=Positive; covid test result=Positive; All hair follicles removed by laser hair removal procedure no longer effective; hormone increases; crying for no reason; feel more hormonally unstable.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Feb2021 12:00 (Lot number: EM9810) at the age of 27 years as dose 2, single and administration date 20Jan2021 12:00 (Lot number: EL3249) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Prothrombin G20210A" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Zofran, reaction(s): "Known allergies: Zofran". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Sep2021, outcome "unknown" and all described as "covid_test_result=Positive"; HAIR GROWTH ABNORMAL (non-serious) with onset 12Feb2021, outcome "unknown", described as "All hair follicles removed by laser hair removal procedure no longer effective"; HORMONE LEVEL ABNORMAL (non-serious) with onset 12Feb2021, outcome "unknown", described as "hormone increases"; CRYING (non-serious) with onset 12Feb2021, outcome "unknown", described as "crying for no reason"; FEELING ABNORMAL (non-serious) with onset 12Feb2021, outcome "unknown", described as "feel more hormonally unstable.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Sep2021) positive, notes: COVID test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of hair growth abnormal, hormone level abnormal, crying, feeling abnormal.  Clinical information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
side of my face got warm, after 3 days it went away; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (side of my face got warm, after 3 days it went away) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (side of my face got warm, after 3 days it went away). At the time of the report, FEELING HOT (side of my face got warm, after 3 days it went away) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
Missed menstrual cycle; PMS systems present for 10 days and no cycle.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 05Apr2021 (Lot number: ER8733) at the age of 37 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLELot number :EN6208 Administration time : 13:00Anatomical location: Right arm), administration date: 12Mar2021, when the patient was 37 years old, for COVID-19 immunisation. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 07Apr2021, outcome "unknown", described as "Missed menstrual cycle"; PREMENSTRUAL SYNDROME (non-serious) with onset 07Apr2021, outcome "unknown", described as "PMS systems present for 10 days and no cycle.". Therapeutic measures were not taken as a result of menstruation delayed, premenstrual syndrome.  Additional information: It was reported that, patient was not allergic to medications, food, or other products. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. 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 had not received any medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible. No further information is expected.
achiness/ ache; chills; Fevering/ feverish; increased heart rate; left arm (Coded to: Tingling); This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 11Mar2021 (Lot number: EN6199) at the age of 61 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FISH OIL, start date: Jan2019; KYOLIC taken for prophylaxis, start date: Jan2019; VITAMIN D [COLECALCIFEROL], start date: Jan2019. The following information was reported: HEART RATE INCREASED (non-serious) with onset 11Mar2021, outcome "unknown", described as "increased heart rate"; PARAESTHESIA (non-serious) with onset 11Mar2021, outcome "unknown", described as "left arm (Coded to: Tingling)"; PAIN (non-serious) with onset 01Apr2021, outcome "unknown", described as "achiness/ ache"; CHILLS (non-serious) with onset 01Apr2021, outcome "unknown", described as "chills"; PYREXIA (non-serious) with onset 01Apr2021, outcome "unknown", described as "Fevering/ feverish". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heart rate increased, paraesthesia.  Additional information: Caller said that on her first dose, she had no reaction and had a little bit in the beginning but immediately went away. For the second dose, she had vomiting, diarrhea, and headache in which she had to go to the emergency care. Caller also added that she did have the usual "achiness, chills, and fevering from it". First dose injected in her arm. Multivitamin took one a day by mouth on an unknown date in Jan2019. Increased heart rate: Caller said after her first dose given, she had increased heart rate and tingling in her left arm that dissipated over ten minutes or so. She said there was no treatment done, it was while she was still there at vaccination site, so they had her stay there for a little bit longer.  Follow-up attempts are completed. No further information is expected.
pt recv vax 21SEP98 & noticed rt shoulder & arm pain 25SEP98 444AM;PE T99.5;P88, BP 94/66, tender deltoid & biceps to touch;no warmth, erythema, mild swelling;
Systemic: anxiety pt stated they were very hot and had rapid breathing-Mild, Additional Details: patient was given an ice pack and water and calmed down and had few issues