chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness at vaccination site; headache; Fatigue; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Mar2021 08:30 (Lot number: EL9269) at the age of 77 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "MGUS Monoclonal paraproteinemia", start date: 2014 (ongoing), notes: MGUS Monoclonal paraproteinemia, Onset Date: 2014, Stop Date: Ongoing; "Barrett's esophagus", start date: 1995 (ongoing), notes: Illness/AE: Barrett's esophagus, Onset Date: 1995, Stop Date: Ongoing; "Degenerative spondylolisthesis", start date: 2010 (ongoing), notes: Degenerative spondylolisthesis, Onset Date: 2010, Stop Date: Ongoing; "Atrial fibrillation", start date: 30Dec2020 (ongoing), notes: Illness/AE: Atrial fibrillation, Onset Date: 30Dec2020, Stop Date: Ongoing; "GERD" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Headache" (unspecified if ongoing); "Bodyache" (unspecified if ongoing); "Multiple Gamopathy of Unknown significance", start date: 2015 (ongoing); "Hyperlipidemia" (ongoing); "Acid Reflux" (ongoing). Concomitant medication(s) included: OMEPRAZOLE taken for gastrooesophageal reflux disease, barrett's oesophagus, start date: 1995 (ongoing); ATORVASTATIN taken for blood cholesterol, start date: 1995 (ongoing); ELIQUIS taken for atrial fibrillation, start date: 2020 (ongoing); TYLENOL taken for headache, pain, start date: 06Oct2021, stop date: 14Oct2021; PRILOSEC [OMEPRAZOLE] taken for gastrooesophageal reflux disease, start date: 2020 (ongoing); LIPITOR taken for hyperlipidaemia, start date: 2020 (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, PFIZER/BIONTECH COVID-19 VACCINE DETAILS:, Date: 19Feb2021 at 09:00, Left Arm, Intramuscular, Batch/Lot number: EL9262), administration date: 19Feb2021, when the patient was 77 years old, for COVID-19 immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 10Mar2021, outcome "recovered" (13Mar2021), described as "soreness at vaccination site"; HEADACHE (non-serious) with onset 10Mar2021, outcome "recovered" (13Mar2021), described as "headache"; FATIGUE (non-serious) with onset 10Mar2021, outcome "recovered" (13Mar2021), described as "Fatigue"; NAUSEA (non-serious) with onset 10Mar2021, outcome "recovered" (13Mar2021), described as "nausea". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected.
3/17 - COVID (think Covid may have effected thyroid levels, noticed a difference in body temp one week after covid) 4/14 - Moderna vaccine 4/15-4/16 - sore arm 4/20 - Chills/body temp change, didn't feel sick 4/21 - Injection site redness, raised bump 4/22-rash on shoulders/chest (went away by 4/24 on its own), mild joint pain 4/23- joint pain (hips) and Erthyma Nodusum symptoms started 4/27-5/3- Did 7 days of prednisone which kepts things at bay 5/4-5/10 - used Advil to help with inflammation didn't work 5/11 - back on prednisone and referred to dermatologist 5/13 - dermatologist, confirmed Erthyma Nodusum, gave Kenalog injection and higher dose of steriods, gave minocylcline and had an allergic reaction to that and switched to omnicef.  Currently still on antibiotic and finishing up steriods.
Patient fainted a few minutes after receiving above vaccines.  Was unconscious  for approx. 30 seconds and came to.  She was startled, pale, clammy and shaking.  Complained of feeling "fuzzy" in her hands and feet.
My left arm went on full out shaking all over the place; but I can't eat anything.; nausea; fever; diarrhea; I was tired; This is a spontaneous report from a contactable consumer. An unspecified age female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for Covid 19 immunization. The patient medical history included diabetic, heart failure. The patient concomitant medications were not reported. It was reported that, After the first dose of the vaccine, on an unspecified date, the patient had experienced nausea, fever, diarrhea that lasted all night and day. She did not eat all day until 6:30 tonight. She supposed to eat breakfast lunch and dinner, but she can't eat anything. She was tired. The patient had a bad tremor in the left leg which was the side she got her vaccine. Her left arm went on full out shaking all over the place. She was diabetic and on blood thinners. I am oxygen. She wanted to know she can get the second shot. They cannot tell her if she should receive the second dose of the vaccine or not. The patient wanted to know she can get the vaccine if she has a medical conditions. The outcome of events was unknown.  Information on the lot/batch number has been requested.
This case was reported by a nurse via call center representative and described the occurrence of fever in a 70-year-old female patient who received Shingrix for prophylaxis. On 10th October 2018, the patient received the 2nd dose of Shingrix .5 ml. In October 2018, less than a week after receiving Shingrix, the patient experienced fever, injection site erythema, injection site warmth, injection site swelling and injection site lump. On an unknown date, the outcome of the fever, injection site erythema, injection site warmth, injection site swelling and injection site lump were unknown. It was unknown if the reporter considered the fever, injection site erythema, injection site warmth, injection site swelling and injection site lump to be related to Shingrix. Additional details were provided as follows: The caller was retired nurse who received 2nd dose of Shingrix on left arm. The caller reported that she experienced fever and swelling, redness and warm to the touch at the injection site. The caller described a knot of about the size of a half-dollar at the injection site. The patient had denied permission to contact their physician.
exp flu like sx w/ heavy cough; cough was described as "an explosion w/in the body disrupting the nl function".  pt stated that as result of coughing, he exp "degradation of sight",bleeding "into the ear";as result of bleeding, lost hearing
Covid-19 Vaccine First dose, Date: 05Jan2021; Covid-19 Vaccine Second dose Date: 22Jan2021; achy; tired; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 37 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jan2021 (Lot number: EK5730) at the age of 37 years as dose 1, single and administered in arm left, administration date 22Jan2021 (Lot number: EL3248) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Psoriasis", start date: 2013 (ongoing); "ADD" (ongoing). Concomitant medication(s) included: CLOBETASOL taken for psoriasis, start date: 2013 (ongoing); VYVANSE taken for attention deficit hyperactivity disorder, start date: 2015 (ongoing). Past drug history included: Adderall for ADD, notes: Used to take Adderall when she was child and switrched to Vivance in 2015. The following information was reported: PAIN (non-serious) with onset Jan2021, outcome "recovered" (Jan2021), described as "achy"; FATIGUE (non-serious) with onset Jan2021, outcome "recovered" (Jan2021), described as "tired"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 22Jan2021, outcome "unknown", described as "Covid-19 Vaccine First dose, Date: 05Jan2021; Covid-19 Vaccine Second dose Date: 22Jan2021".  Additional information: Patient reported that with the first and second dose of the Covid-19 vaccine, she was tired and achy, but that was it. The symptoms for that only lasted 12-24 hours though. Patient did not receive any other vaccinations within 4 weeks prior to first administration of covid vaccine.   No follow-up attempts are possible. No further information is expected.
Information has been received from a 24 year old female doctor of pharmacy with no known drug reactions/allergies or pertinent medical history who "a few years ago" was vaccinated with the 3 doses of GARDASIL. Concomitant therapy included YASMIN. It was reported that on 15-SEP-2009 the patient got PAP results that said there was detected about 10 HPV types which include 16 and 18 HPV DNA. The patient sought medical attention by an office visit. It was noted that the doctor of pharmacy would be going to another physician for more tests. Additional information has been requested.
PREVNAR give Rt. deltoid 12-12-16: Patient noticed on 12-17-16 redness, swelling, burning sensation on surrounding area of vaccination. Had Dr. appt. 12-20-16 - Localized reaction noted.
2/16 11:30 a.m. shots received. 2/17 2 a.m. fever, chills, vomiting. Today with both eye swelling, HA, dizziness, decrease po. Pt arrived from out of the country 2 days ago. Pt temp 100.9, B/P 107/76, Pulse 127 done by MD.
This spontaneous report as received from a certified medical assistant (also reported as healthcare worker) refers to a female patient of unknown age. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with GARDASIL (unknown strength and dose) intramuscular. Concomitant medications were not reported. On an unknown date, the patient experienced shortness of breath after receiving a dose of GARDASIL. Therapy with GARDASIL was discontinued. The patient sought medical attention and went to an unspecified Emergency Room and had unspecified treatment. The outcome of the event was unknown. Causality assessment was not provided. There was no product quality complaint involved. Additional information has been requested.
His son experienced arm sore and it hurts when taking a deep breath.; His son experienced arm sore and it hurts when taking a deep breath.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 12Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), PAINFUL RESPIRATION (non-serious) all with onset Apr2021, outcome "unknown" and all described as "His son experienced arm sore and it hurts when taking a deep breath.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sore arm at injection site after injection. Next day at noon arm sore, swelling and soreness from right side neck to injection site, bad chills, lightheaded, head felt foggy, slight headache, nausea and fever of 100.4
I was hospitalized on 11/11/22 for chest pain and tachycardia. Cardiac CT and X Ray were normal, but troponin levels were elevated  at .33 (about 3.5 times higher than normal). I had been feeling very weak and tired for ~3 days before the event. On the day of the event, I had gone on a bike ride (as usual, I am a cyclist and ride 3-5 times/week) and developed chest pain afterwards. As the pain worsened, my heart rate suddenly increased to 130 bpm for ~5 mins while I was at rest. I was short of breath during this time, and the pain was worse afterwards. I then decided to go to the hospital, where I was kept for 22 hours while they tried to determine what happened. Through process of elimination, I was diagnosed with mild peri- and/or myocarditis. My white blood cell counts were normal, but I had elevated inflammation markers and troponin.
Burning, itching, redness. Bump at site of injection. ER diagnosis: cellulitis.
Extreme fatigue, headaches, migrane, vertigo. Pain on right side, pain on left side, heart attack, temporary paralysis on right side, temporary blindness in right eye, pain in kidneys, 2nd heart attack. Contacted the CDC on three different occasions, was told they didn't know what to do. Referred to supervisor. No calls back. Referred to the state department of health. Also told didn't know what to tell.
Fever 101-103 5/23/11. Pink pinpoint papules on both thighs lateral aspect 5/24/11. At office visit 5/24/11 acute tonsillitis.
After dose 1  - Headache and slight high pitched ringing in head or ears  After dose 2 - Headache and loud high pitched ringing in head or ears. Affecting my mental health and causing irritability  I need it to stop!
Information has been received from a physician concerning a female who on 30-NOV-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast). On 30-NOV-2007, the patient experienced syncopal episode. The patient finish her series and receive her third dose of GARDASIL vaccine, on 21-APR-2008. On approximately 21-JUL-2008 the patient has another dizzy, clammy feeling episode. The grandmother who reported this to the physician mentioned it was her third episode already. The patient sought medical attention. Additional information has been requested.
Information has been received from a registered nurse concerning a child who was vaccinated with varicella virus vaccine live (site not reported).  Subsequently, the pt developed chicken pox with over 200 lesions. Unspecified medicaL attention was sought. No further information is available
Pt recvd vax & 1hr p/vax exp swelling, arm numbness & severe h/a;
This spontaneous report was received from a medical assistant referring to a 12 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # N002720. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009215 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009215 is being deleted from our files and the case is consolidated into case # 1711USA003937 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
I was rushed to the hospital and I thought it was from the cyst on my kidney. After a cat scan, they found 1 and a half liters of liquid around my heart. I was transferred to a larger hospital and had surgery to drain the fluid the next morning. I was hospitalized for 3 days. I started having chest pains in the upper left area of my chest near the breast bone. It has worsened since and radiates down my left arm. They are still currently treating me with Gabapentin for the pain in your chest. The heart pain is ongoing. I have had 2 additional surgeries since. They discovered that I had developed an aneurysm in my brain which could not be removed. A mesh device was placed in my head to stop the aneurysm from going so I am receiving continuous care from a doctor.
Starting immediately following the vaccination at 8:15a on 26Jan2021: pain at injection site (moderate) for approximately 36 hours duration.  Starting at 10pm on 26Jan2021 the following AEs were noted: chills (mild) for approximately 2 hours duration, headache (mild) for approximately 24 hours duration, clammy (mild) for approximately 24 hours duration, overall body ache (mild) for approximately 24 hours duration, and feeling of restless leg syndrome, but throughout whole body (moderate) for approximately 12 hours duration. Tylenol was taken twice during the period of 10p 26Jan2021 through 12p 27Jan2021 for symptoms.
product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech; product=COVID 19 Treatment, brand=Paxlovid/vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from a contactable Physician via product quality group.  A 61-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EH9899), as dose 1,single, administered via unspecified route in left arm, on 16Dec2020 and received second dose of BNT162b2,(Lot Number: E L1283), as dose 2,single, administered via unspecified route in left arm, on 15Jan2021 and received dose 3 (booster) of BNT162b2 (Lot number: EW0172) on 27Sep2021 in left arm for covid-19 immunisation, ( age at vaccination was 60 years). The patient also received coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05May2022 as dose 4 (booster), single (Lot number: 002M21A), in left arm for covid-19 immunisation. The patient relevant medical history included hypertension, Prostate cancer and "CAD" (unspecified if ongoing). Concomitant medication(s) included Amlodipine [AMLODIPINE BESILATE], stop date: 16May2022; ASPIRIN (E.C.); Atorvastatin; CALCIUM CARBONATE and SILDENAFIL taken for an unspecified indication, start and stop date were not reported.. The patient experienced vaccination failure and COVID-19. It was reported that, the patient was Covid positive rebound after taking Paxlovid. Covid symptom onset was 13May2022 (day 0). He felt well quickly after starting Paxlovid on day 3 of illness (16May2022) and took full 5 days of medication. He had negative Covid antigen test on day 10 (23May2022) of illness. But on 24May2022 and 25May2022 he tested positive again all, (the repeat tests done due to recurrent symptoms). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23May2022) Negative, notes: He had negative Covid antigen test on day 10 (23May2022) of illness; (unspecified date) Positive, notes: report Covid positive rebound after taking Paxlovid; (24May2022) Positive, notes: But on 24May and 25 he tested positive again; (25May2022) Positive, notes: But on 24May and 25 he tested positive again; (01Jun2022) Negative, notes: He recovered and on 01Jun2022 tested negative again. Therapeutic measures were taken as a result of the events. The outcome was recovered on 01Jun2022.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
I didn't have any immediate symptoms - if I pushed on my arm I could tell it was sore . Recently, I had headaches - I rarely get headaches. And feeling tired. I had a little bit of a dry cough. I knew people around people around the office had been exposed to COVID. I was tested. Labored breathing - but not bad. Tired and fatigues - a little bit of heachaches. Now I'm coughing up some phlegm but not a lot. On Sunday morning, I lost my sense of taste and smell. They gave me a five pack of antibiotics - Zithromax and gave me Albuterol inhaler.  The doctor told me that what I was currently experiencing would probably be the extent of my symptoms except if my breathing became more labored then go straight to ER.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a four-year-old male patient. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Dec-2010. The patient received the expired FLUMIST on 22-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
Redness , swelling and hives noted approximately 24 hours after receiving vaccine. Mom gave Benadryl dosing . Reported improvement after dosing with Benadryl. Continued to give for a couple of days every 8 hours. Continued improvement of redness, swelling and hives after 2-3 days. No other symptoms noted.
sudden death; getting COVID; getting COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUDDEN DEATH (death), outcome "fatal"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with latency 1 week after the suspect product(s) administration, outcome "unknown" and all described as "getting COVID". The patient date of death was unknown. Reported cause of death: "sudden death". It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300166993 same reporter/drug/event, different patient;; Reported Cause(s) of Death: sudden death
Upon administration of HPV(Gardasil) #3, pt developed lacey, red, flat rash on upper arm at site and extending across upper neck and involving opposite upper arm. Occurred within seconds of injection. Benedryl 25 mg given po. Redness/rash improved after approx. 20 minutes with no further complaints.
She cannot move/use her arm at all; Her arm swelled up  her entire arm, down to her hand; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (She cannot move/use her arm at all) and VACCINATION SITE SWELLING (Her arm swelled up  her entire arm, down to her hand) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (She cannot move/use her arm at all) and VACCINATION SITE SWELLING (Her arm swelled up  her entire arm, down to her hand). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (She cannot move/use her arm at all) and VACCINATION SITE SWELLING (Her arm swelled up  her entire arm, down to her hand) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up was received on 23-APR-2021. All events' outcome was updated to recovered/resolved.