chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Two days later, he passed away.; felt fatigued; fever; achy; got the booster shot; got the booster shot; This is a spontaneous report from a non-contactable pharmacist. An elderly male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscularly on 28Sep2021 (Batch/Lot number was not reported) as dose 3 (booster), single for COVID-19 immunization (administered in a Pharmacy or Drug store); and influenza vaccine via an unspecified route of administration on 28Sep2021 (Batch/Lot number was not reported) for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient got the booster shot on 28Sep2021. On 29Sep2021, the patient felt fatigued, fever, and achy. The patient took paracetamol (TYLENOL) and felt a little bit better. Two days later, he passed away. The outcome of felt fatigued, fever, and achy was unknown. It was not reported if an autopsy was performed. The cause of death was not reported. The patient died on 30Sep2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal relationship the possibility of causal association between the event death and the suspect drug BNT162B2 cannot be excluded.    The impact of this report on the 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Two days later, he passed away.
Pneumovax vaccine given 9/28/05. Pt returned to office on 9/30 with lg welt around injection area.
No adverse event; Dose 1 given on 22-feb-2021 and dose 2 given on 15-Mar-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 given on 22-feb-2021 and dose 2 given on 15-Mar-2021) and NO ADVERSE EVENT (No adverse event) in an 85-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 given on 22-feb-2021 and dose 2 given on 15-Mar-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 given on 22-feb-2021 and dose 2 given on 15-Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 given on 22-feb-2021 and dose 2 given on 15-Mar-2021).    No concomitant medications were reported.  No adverse events were reported.  Patient's third dose date was reported as 09-Nov-2021.  No treatment medications were reported.   This case was linked to MOD-2022-638072 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2022: Live Follow up contains no new information.
Left arm and left leg weakness following administration of the vaccine.  She had similar symptoms with a stroke one year ago, but MRI reveals no new acute stroke symptoms.  Her symptoms had improved over the course of the last year and worsened after the COVID vaccine.
On 01/02/2023, I tested positive for COVID-19. I had runny nose, severe sore throat three days, fever, hurt to swallow, sore all over, hacking and then dry cough. My symptoms lasted two weeks. I had no energy. It hurt to think. At the walk in clinic, due to my comorbidities they decided not to do PAXLOVID. I took over the counter medications. I had no appetite and lost weight. I took ROBITUSSIN and TYLENOL. After two weeks, I became progressively better.
PAIN AT INJECTION SITE THAT BEGAN WITH INJECTION. PAIN HAS INCREASED GRADUALLY AND HAS NOT GONE AWAY. PATIENT HAS TREATED PAIN WITH ALEVE 220MG, 2 TABLETS TWICE A DAY IN THE MORNING & AT BEDTIME, SUPPLEMENTED WITH HEAT OR ICE. PAIN CONTINUES TO INCREASE RADIATING DOWN THE ARM. PATIENT REPORTED THIS TO ME ON 11/3/21; BECAUSE PAIN NOT SUBSIDED & MOBILITY IS DECREASED. PATIENT STATES SHE THOUGHT SHE BROKE HER WRIST, BECSAUSE PAIN WAS SO INTENSE. PATIENT ALSO HAS A SORE JAW, THIS STARTED ON 11/2/21.
Received vaccine (L) deltoid 17 Nov 09. (+) Redness, (+) swelling, (+) hot to touch from shoulder to elbow (+) itching - slight (mild) rash directly over injection site - Pt taking CLARITIN for allergies.
This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age. On an unknown date, the patient might have been vaccinated with either VARIVAX (lot # M045205, exp. date: 11-NOV-2018 or lot#N014366, exp. date: 05-SEP-2019 or lot#M033211, exp. date: 13-JUL-2018), or ZOSTAVAX (lot# M041511, exp. date 08-JAN-2018) or PROQUAD (recombinant human albumin (rHA)) (lot#N010866, exp. date 01-OCT-2018). Concomitant therapies included sterile diluent (STERILE DILUENT). Additional information has been requested.
Highest fever recorded 101.2, chills, joint pain, muscle aches, fatigue, injection site pain,  mild headache, and mild nausea
IBS flared up with all foods and environments; Physical side effects; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0172) via an unspecified route of administration on 23Apr2021 at 08:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included metal implant from vehicle accident in 2010 and episodes of irritable bowel syndrome (IBS) on and off for ten years. It was reported that the most extreme and painful episodes of IBS were directly after diagnosis. The patient had no known allergies. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included oxycodone (MANUFACTURER UNKNOWN) and unspecified nonsteroidal anti-inflammatory drugs (NSAIDs) (MANUFACTURER UNKNOWN), both were for unspecified indications from unknown dates and unknown if ongoing. On 23Apr2021 at 18:00, the patient's IBS flared up with all foods and environments. It was reported that most other physical side effects were gone but the IBS episodes were constant. On 25Apr2021, the patient would be purchasing dicycloamine products (MANUFACTURER UNKNOWN) to control symptoms and prepare for second dose. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of physical side effects was recovered on an unknown date in Apr2021 and outcome of the event IBS flared up with all foods and environments was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a consumer concerning her daughter who was vaccinated with GARDASIL. The consumer reported that he had nothing to live for because GARDASIL killed his daughter. It was unknown if the patient sought medical attention. No further information is available.
Headache, pain in left arm, fever, chills,  body aches, nauseous, fatigue
On 10/19/2016 mother called to state that patient had rash on back that were white and raised not fluid filled.  Mom told patient to take a dose of Benedryl on 10/18/2016 and rash went away. It returned then in later in evening so mom had her take another dose of Bendryl.  She is at Universit.  She let mom know on 10/19/2016 that the rash resolved.  Mom thought she should report it since she had gotten the vaccination and a flu shot.
eye lid swelling; Pain in left eyelid that felt like a bruise about 24 hours after shot; This is a spontaneous report from a contactable consumer reporting for herself.  A 43-years-old female patient received the first dose of  bnt162b2 (BNT162B2; Lot # EM9810) vaccine , via an unspecified route of administration in the left arm on 05Feb2021 14:45 at single dose for covid-19 immunisation .  The patient medical history was not reported.  Concomitant medication included doxycycline (DOXYCYCLINE), loratadine, pseudoephedrine sulfate (CLARITIN-D).  The patient experienced pain in left eyelid that felt like a bruise about 24 hours after shot  on 06Feb2021 15:00 with outcome of recovering , eye lid swelling  on 07Feb2021 02:45 with outcome of recovering. Both the events were considered non serious. The patient received Cold compress and Benadryl on advise from on call to treat the events.  Follow up information has been requested.
pt had localized lt deltoid area was warm to touch, reddened from mid delt to shoulder w/raised bumps around entire arm; pt stated that this react started 27DEC93 in an 0700; seen in ER 29DEC93;
Received vaccine on 12/28/2020. started having muscle aches, ear pain, chest congestion, cough, fatigue, nasal drainage, HA, nausea and vomiting, chills on 12/29/20. Went to urgent care on 1/1/21 and diagnosed with viral upper respiratory tract infection.
Approximately 2-3 hours after getting shot I started to feel flush my temperature was slightly higher than my normal at 98.9 (my normal is about 97.7). I also felt a little tired, I work 2nd shift so I went to work as normal. About 4 or 5pm the fatigue started to worsen and it was difficult to do my job I also felt nauseous, I struggled to finish my shift because of the fatigue. When I came home at 11pm I went straight to bed. When I awoke in the morning the fatigue was worse and it was difficult to stay awake but the nausea had passed. I was extremely tired all day until about 8pm or so when the fatigue started to lessen. By the next morning I was still a little tired but I could resume my normal schedule although I felt like I didn't get a good nights sleep. By Saturday morning (20th) I was not feeling any adverse effects.  I have sleep apnea which I forgot to list on medical conditions and I can't go backwards on the form so I am including it here.
Vaccine administration error: Patient received Moderna on May 7, 2021. Pfizer given June 9, 2021. No adverse reaction at time of injection or as of June 10, 2021 when pharmacist followed up.
Hot/cold sweats, fatigue, nervousness, loss of appetite, fear of sleep. Been to ER twice and doctor 1. Say they can't do anything.
Had Td and Hep B #2 at 4:30pm 8/20/02. Began s/s at 8am 8/21/02 of fever 102, chills, joint pain, headache, weak.
Patient got COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient got COVID-19) in a child male patient 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 COVID-19 (Patient got COVID-19). At the time of the report, COVID-19 (Patient got COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided.  It was reported that It was unknown if patient experienced any symptoms after getting 1st dose of the vaccine, or if any treatment was given for the symptoms. The patient was listed in a Moderna clinical trial.   No treatment medication information provided.  Company Comment: This is a spontaneous case concerning  a child male patient with no reported medical history, who experienced the unexpected non-serious AESI events of Covid-19. The events occurred on an unknown date after the first dose of mRNA-1273  Vaccine which was administered on an unknown date. It was reported that It was unknown if patient experienced any symptoms after getting 1st dose of the vaccine, or if any treatment was given for the symptoms. The patient was listed in a Moderna clinical trial. No treatment medication information provided. Outcome of the event was unknown, at the time of report. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning  a child male patient with no reported medical history, who experienced the unexpected non-serious AESI events of Covid-19. The events occurred on an unknown date after the first dose of mRNA-1273  Vaccine which was administered on an unknown date. It was reported that It was unknown if patient experienced any symptoms after getting 1st dose of the vaccine, or if any treatment was given for the symptoms. The patient was listed in a Moderna clinical trial. No treatment medication information provided. Outcome of the event was unknown, at the time of report. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Information has been received from a registered nurse concerning an 8 year old male who was vaccinated on 05/31/2000 with a dose of varicella virus vaccine live (Oka/Merck).  The patient was seen in November 2003 with a few red lesions. The child was noted to have chickenpox breakthrough.  Unspecified medical attention was sought.  There was no product quality complaint.  The reported indicated that 19 other patients were vaccinated with a dose of varicella virus vaccine live (Oka/Merck) and developed chickenpox breakthrough/shingles.  No further information is expected.
Information has been received from a Certified Medical Assistant concerning a male patient who on 14-SEP-2010 was vaccinated with the first dose of ROTATEQ (lot # and expire date not reported), 2 ml, per oral. On 15-NOV-2010 the patient was vaccinated with the second dose of ROTATEQ (lot # and expire date not reported), 2 ml, per oral and regurgitated an unknown quantity of his second dose. No adverse effect reported. Additional information has been requested.
now I have had a period every two weeks; I missed my first period after getting vaccinated; had a period and another one 2 weeks later / now I have had a period every two weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 (Lot number: EW0173) at the age of 45 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE [LEVOTHYROXINE SODIUM]. Past drug history included: Amoxycillin, reaction(s): "Known allergies: Amoxycillin", notes: Known allergies: Amoxycillin. Vaccination history included: Bnt162b2 (lot number=EW0169,, dose number =1,, vaccine_location=Left arm), administration date: 14Apr2021, when the patient was 45 years old, for COVID-19 immunization. The following information was reported: AMENORRHOEA (non-serious) with onset 05May2021, outcome "unknown", described as "I missed my first period after getting vaccinated"; POLYMENORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "had a period and another one 2 weeks later / now I have had a period every two weeks"; MENSTRUAL DISORDER (non-serious) with onset 15Dec2021, outcome "unknown", described as "now I have had a period every two weeks". The events "i missed my first period after getting vaccinated", "had a period and another one 2 weeks later / now i have had a period every two weeks" and "now i have had a period every two weeks" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of amenorrhoea, polymenorrhoea, menstrual disorder.  Additional information: Patient missed her first period after getting vaccinated, almost 2 months. Then had a period and another one 2 weeks later. Next month normal and now she had a period every two weeks since 15Dec. No other vaccine received in four weeks. No Covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
No menstrual cycle.  I am 10 days late and going. I should have started 3/24/21 today is 4/2/21 . I am very regular. I have an IUD. I took a pregnancy test which was negative. My breasts are also very sore. I have not started menopause either.
Chiils, total body aches, fever 102.4 within 9 hours of administration
HSV-negative vulvar ulcers reported /after the first dose of the Pfizer-BioNTech COVID-19 Vaccine; This is a literature report for the following literature source(s): Journal of Pediatric and Adolescent Gynecology, 2022; Vol:35(2), pgs:234, DOI:10.1016/j.jpag.2022.01.110.  A 14-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "post-menarchal" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VULVAL ULCERATION (medically significant), outcome "recovered", described as "HSV-negative vulvar ulcers reported /after the first dose of the Pfizer-BioNTech COVID-19 Vaccine". The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: Negative, notes: For ANCA associated vasculitis, Further testing was; Antiphospholipid antibodies: Negative, notes: Further testing was; Biopsy: demonstrating chronic inflammation; Cytomegalovirus test: Negative; Epstein-Barr virus test: Negative; Herpes simplex test: Negative, notes: vulvar ulcers reported; HIV antibody: Negative; behcets: Negative, notes: disease, Further testing was; Negative, notes: Further testing was; Polymerase chain reaction: Negative; Treponema test: Negative. Therapeutic measures were taken as a result of vulval ulceration.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event VULVAL ULCERATION and BNT162B2.  The impact of this report on the 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202201104494 Same Article/drug/event and different patient;US-PFIZER INC-PV202200052891 Same Article/drug/event and different patient;
Slight difficulty breathing like labored breathing 1 hour after booster/Difficulty breathing; Fast/racing heartbeat 1 hour after booster; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Slight difficulty breathing like labored breathing 1 hour after booster/Difficulty breathing) and HEART RATE INCREASED (Fast/racing heartbeat 1 hour after booster) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069H21A and 007821A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus, Kidney disorder and Hypertension. Concomitant products included INSULIN DEGLUDEC (TRESIBA FLEXTOUCH), DILTIAZEM, IRBESARTAN, CARVEDILOL, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), ROSUVASTATIN CALCIUM (CRESTOR) and UBIDECARENONE (COQ10 [UBIDECARENONE]) for an unknown indication.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, the patient experienced DYSPNOEA (Slight difficulty breathing like labored breathing 1 hour after booster/Difficulty breathing) and HEART RATE INCREASED (Fast/racing heartbeat 1 hour after booster). On 16-Dec-2021, DYSPNOEA (Slight difficulty breathing like labored breathing 1 hour after booster/Difficulty breathing) and HEART RATE INCREASED (Fast/racing heartbeat 1 hour after booster) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Dec-2021, Blood pressure measurement: normal (normal) Normal. On 20-Dec-2021, Electrocardiogram: normal (normal) Normal.         The patient developed adverse events about 1 hour after the booster shot. They lasted for a couple hours.  The patient thought that her breathing was labored because of the fast/racing heartbeat as the heartbeat and breathing goes hand in hand. The heart and breathing was not severe enough to go to the hospital; she was not gasping for oxygen.  The patients concomitant included Diltiazem 24 hour extended release.   No treatment medication were provided.  On 20-Dec-2021, the patient went to see her cardiologist for a routine check up but she had forgotten to mention the adverse events to the cardiologist.  On 20-Dec-2021, the patient again felt difficulty breathing when she had a mask on, and was exerting herself, she was not sure if this was noteworthy. The difficulty in breathing was resolved when she took off her mask.  The patient had no history of myocarditis or pericarditis.   This case was linked to MOD-2021-420648 (Patient Link).
COVID 19 Treatment; COVID 19 Treatment; Vaccine_brand_other=Moderna; This is a spontaneous report received from contactable reporter (consumer). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 as dose 1, single (Lot number: EL9269), in left arm, on 12Mar2021 as dose 2, single (Lot number: E16200), in left arm and on 05Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 68 years, in left arm for COVID-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10May2022 as dose 4 (booster), single (Lot number: 056MZ1A), in left arm and on 13Sep2022 as dose 5 (booster), single (Lot number: AS714SB), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). Concomitant medication included: L-THYROXINE [LEVOTHYROXINE], start date: Jan2021. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10May2022, outcome "unknown", described as "Vaccine_brand_other=Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, COVID-19. Clinical course: The patient was treated with Paxlovid for COVID- 19 treatment from 08Mar2023 to 13Mar2023. She has no known allergies.