chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tongue was swollen/swollen tongue; not able to swallow; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Oct2023 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: DYSPHAGIA (hospitalization) with onset 04Oct2023, outcome "unknown", described as "not able to swallow"; SWOLLEN TONGUE (hospitalization) with onset 04Oct2023, outcome "unknown", described as "tongue was swollen/swollen tongue". The events "tongue was swollen/swollen tongue" and "not able to swallow" required emergency room visit. The clinical course was reported as follows: "04Oct2023, my husband woke up not able to swallow because his tongue was swollen and we had to go to the ER and they admitted him".   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
High fever for 24 hours, extreme fatigue for 48 hours. Severe fatigue and malaise and difficulty breathing and concentrating and dizziness ever since symptoms began to kick in, 9 days ago.
pt recv vax; exp fever, rhinitis and cough; recovered 14-15 days later;
pt recvd vax sx getting worse in inactive state, i.e. sleeping resting-arm becomes disfunctional; have to lift it w/other arm; very painful; during day it eases up, but have to take anti-inflam's; pain in always present; given in rt arm,
Atrial Fibrillation with Rapid Ventricular Response; This is a spontaneous report from a contactable physician (patient himself). A 66-year-old male patient received third dose (booster) of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot number: 301308A), via an unspecified route of administration, administered in the right arm, on 29Sep2021 20:30 (at the age of 66 years) at a single dose for COVID-19 immunization. The patient received his vaccine at a pharmacy or drug store. Medical history included sepsis from Feb2019 due to LLE erysipelas on unspecified date, C-spine stenosis with decompression from Jun2015, and complicated by RUE C5 palsy on unspecified date. The patient has no known allergies. The patient has no Covid prior vaccination. The patient was not tested for Covid post vaccination. Concomitant medications included tadalafil and latanoprost eye drops. The patient previously received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot number: EJ1685) administered in the left arm on 17Dec2020 at 06:00PM (at the age of 65 years) for COVID-19 immunisation, second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot number: EL0142) administered in the left arm on 06Jan2021 at 11:00PM (at the age of 66 years) for COVID-19 immunisation, and Influenza Fluzone High Dose Quad Strength administered in the left arm on 22Sep2021 (at the age of 66 years) for immunisation. The patient experienced atrial fibrillation with rapid ventricular response, first episode, duration of 25 min on 13Oct2021 22:45 with outcome of recovered on 13Oct2021 23:10. The event was ECG confirmed on 13Oct2021. No treatment was received for the event. The event resulted in emergency room/department or urgent care.; Sender's Comments: Based on the available information in the case, the causal association between the event atrial fibrillation 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.
Chronic fatigue starting a few weeks after administration of the vaccine which has lasted and is ongoing. Patient needs to take 1-2 naps per day to maintain function
Information has been received from an office manager concerning a 15 year old female with a penicillin allergy who on 31-JUL-2007 was vaccinated with Gardasil.  There was no concomitant medication.  Two days after vaccination, on 02-AUG-2007, the patient developed tremors of the hands and feet.  The symptoms lasted for six days.  The patient came to the office on 25-AUG-2007 to report the tremors.  As of 31-AUG-2007 the patient had no symptoms.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007.  Initial and follow-up information has been received from an office nanager concerning a 15 year old female student with PENICILLIN allergy and no medical history, who on 31-JUL-2007 at 16:30 was vaccinated intramuscularly in the upper arm with a first dose of GARDASIL (Lot# 658222/0927U).  There was no concomitant medication. Two days after vaccination, on 02-AUG-2007, the patient developed tremors of the hands and feet.  The symptoms lasted for about six days.  The patient came to the office on 25-AUG-2007 to report the tremors.  At the time of the office visit the patient had no symptoms.  There was no ataxia, or dizziness (previously reported as of 31-AUG-2007 the patient had no symptoms).  No laboratory diagnostic studies were performed.  No product quality complaint was involved.  At the time of this report, the patient had recovered.  Additional information is not expected.
The unusual symptoms started on day 10. Itching increased to extreme itching,  extremely HOT,  red rash,  center clear.  Went from top of shoulder and over next 4 days expanded to elbow crease and toward inner arm.  Today,  2/1/2021 starting to receed.
Pt vaccinated with DTP/OPV extreme irritability, unusual cry; poor feeding within several hrs of receiving DTP injection rectal temp 103.2 "moaned" a lot had subsequent ER visit; Did develop loose stools the evening of the shot.
Recurrent solitary urticarial lesion with pruritus at Jennerian scar site of previous smallpox vaccine. Rash, oth nonspecific skin eruption, Disturbance of skin sensation. We did biopsy evaluation and tryptase, showed some abnormalities but did not meet clinical diagnosis. We have given him a dx of recall urticaria, with trx of prn ZYRTEC.
I was 5 weeks pregnant at the time of taking my COVID booster.  Later we found that the fetus stopped growing around the same time as when I received the booster leading to miscarriage.
Extreme muscular soreness, left shoulder and arm, not specifically at the site of the injection.
Case number PHEH2013US020527 is an initial spontaneous report received from a nurse on 30 Sep 2013 with the follow-up received on 28 Feb 2014. This report refers to a 43-year old adult female patient. In the morning of 26 Sep 2013, she was vaccinated intramuscularly with FLUVIRIN (batch number: 1308401, expiry date: Mar 2014) at 0.5 ml in the deltoid. It was reported that before vaccination, FLUVIRIN was placed in the shipping container at room temperature for 72 hours and later administered to the patient. No adverse event was reported following this medication error. Follow-up received from nurse on 28 Feb 2014: Updated date of birth, vaccination site and time.
Haven't had my period since vaccination. I had only missed 1 period before vaccination and was pretty consistent on them.  Was not experiencing menopause.  At my annual women's health check, uterus and ovaries still looked normal and healthy.  I haven't had a period since vaccination.
Severe body aches and little headache,nausea started around 1715 on 01/14/2021.headache and nausea was gone another day but body aches ended around 3-4 days.
His symptoms felt more like the flu than anything else; Fever; Chills; felt like crap; area where he received the shot was hot to the touch; little painful; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like crap), VACCINATION SITE WARMTH (area where he received the shot was hot to the touch), INFLUENZA LIKE ILLNESS (His symptoms felt more like the flu than anything else), PYREXIA (Fever) and CHILLS (Chills) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 092D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced VACCINATION SITE WARMTH (area where he received the shot was hot to the touch) and VACCINATION SITE PAIN (little painful). On 04-Aug-2021, the patient experienced FEELING ABNORMAL (felt like crap), INFLUENZA LIKE ILLNESS (His symptoms felt more like the flu than anything else), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with NAPROXEN SODIUM (ALEVE) for Fever, at a dose of 1 dosage form. On 04-Aug-2021, FEELING ABNORMAL (felt like crap), VACCINATION SITE WARMTH (area where he received the shot was hot to the touch), INFLUENZA LIKE ILLNESS (His symptoms felt more like the flu than anything else), PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE PAIN (little painful) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details were provided.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. The pharmacist reported that on an unknown date the patients were vaccinated with PNEUMOVAX23 (lot #, expiration date, dose, route and anatomical located unspecified), GARDASIL (lot #, expiration date, dose, route and anatomical location unspecified) and PEDVAX HIB (lot #, expiration date, dose, route and anatomical location unspecified). The pharmacist reported that vaccines were possibly administered after being stored improperly. No adverse effects reported. The patient's outcome was unknown. Additional information has been requested.
Beginning at 10pm: chills, fever (102), headache, body aches 4am: took Aleve (2 caplets) 6am: fever (100), body aches, headache 9am: temperature returned to ~98.8 Body aches and fatigue continued until about 5pm
Extreme dizziness for 3 days, onset about 6 hours after dosage.  Dizziness to the point it was difficult to walk.
Pt stated that his neck region felt warm and he had an emesis episode x1.  Vitals were taken and noted to be stable wnl. Pt was assessed by MD and monitored an additional 15 min and was noted to be fine with no other s/e noted.
COVID vaccine 1st dose was given on 9/17/2021 and 2nd dose on 9/24/2021
Information has been received from a medical assistant concerning a female who was vaccinated with a dose of varicella virus vaccine live and subsequently, developed chickenpox. It was reported that the family was tested for chickenpox when the child developed chickenpox. Unspecified medical attention was sought. No further information was given at the time of this report and the pt's outcome was unk. There was no product quality complaint involved. Additional information has been requested.
Blood pressures 106/78 (pulse 111), 116/74 (pulse 93), O2 sat 98%.
Information has been received from a registered pharmacist concerning a 77 year old female patient who on 12-DEC-2008 was vaccinated subcutaneously in the left arm with a one dose of ZOSTAVAX (Oka/Merck) (LOT # 662991/1619X). On 15-DEC-2008 the patient developed tenderness to the touch down the injection arm but not at the injection site of the left arm. The patient stated "it feels like I'm going to break out in a cold sore". The pharmacist also reported that the patient had an upset stomach. The tenderness has begun to resolve without sequelae. Additional information is not expected.
Projectile vomiting immediately upon leaving clinic (while in parking lot), continued an additional 4-5x that day followed by the development of urticaria on and off for the next 3 days.
This spontaneous report as received from a medical assistant who refers to multiple unspecified patients of unknown age. On an unknown date the patients were vaccinated with PROQUAD (lot # L030585, expiration date: 10-FEB-2017) and (lot # M007964, expiration date: 15-AUG-2017), subcutaneous. Other suspect therapies included VARIVAX (Lot # L037559, expiration date: 29-SEP-2017), (refer to MARRS # 1608USA000350). The medical assistant reported that multiple unspecified patients received either VARIVAX or PROQUAD that were improperly stored. No adverse effects reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to PROQUAD. No further information was provided. Additional information has been requested.
mild case of covid on August/ tested positive; mild case of covid on August; This is a spontaneous report received from a contactable consumer (spouse of patient) from a Pfizer-sponsored program. A male patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 on Feb2021 (Batch/Lot number was not reported), and dose 2 via on Mar2021 (Batch/Lot number was not reported), both as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient received the 1st and 2nd doses on February and March. He got a mild case of COVID in August (24Aug2021, tested positive). He tested negative in 17Sep2021. The patient had an appointment to get the booster "today" (report date: 27Sep2021). The reporter was interested in knowing if it was not dangerous for the patient to get the booster. The reporter thought that maybe the patient's antibodies were still too high.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Subsequently post vax, the pt developed an injection site lump, redness, and swelling. She also had stomach cramps, and diarrhea.
Came in clinic on 03/24/2009 c/o severe pain at injection site. Unable to lift arm due to pain. Fever at injection site and erythema noted at injection site. Edema of upper arm noted. Referred to MD due to severe pain pt was having 6 days post injection with no improvement.
Patient begun complaining of feeling like head was heavy and she was weak. She complained of feeling a "vice like" pressure to occipital region of skull 7/10 on pain scale that worsened over a 10 minute period. Patient then became increasingly drowsy and felt she couldn't keep head upright.  She was sent to ER for evaluation.
Immediately following administration of Influenza vax, pt exp edema, pain, & erythema @ inject site; Area affected was approx 8 mm in diameter;
Event occurred after 2nd dose. Patient was diagnosed with COVID Folic acid, Tylenol In-patient
erratic heart rate; elevated heart rate; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE IRREGULAR (erratic heart rate) and HEART RATE INCREASED (elevated heart rate) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced HEART RATE IRREGULAR (erratic heart rate) and HEART RATE INCREASED (elevated heart rate). At the time of the report, HEART RATE IRREGULAR (erratic heart rate) and HEART RATE INCREASED (elevated heart rate) outcome was unknown. Not Provided      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.
I tested positive; I tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EN5318), on 15Feb2021 as dose 2, single (Lot number: EN5318) and on 09Dec2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "various antibiotic sensitivities" (unspecified if ongoing); "latex contact" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Jun2022, outcome "recovered" and all described as "I tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jun2022) Positive, notes: covid test type post vaccination=Nasal Swab, covid test name post vaccination=BinaxNow. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical Course: According to Pfizer employee training having covid 19 symptoms after vaccination counts as adverse event. I tested positive and symptoms were body aches, chills but not fever on my thermometer, tired, turned into head cold with snot and cough, sinus headache. Patient had not received any other vaccines within 4 weeks before COVID vaccine. Patient had not diagnosed with COVID-19 before vaccination and diagnosed with COVID-19 after vaccination. Facility type vaccine: Workplace clinic. Known allergies: various antibiotic sensitivities and latex contact. Other medical history: No.  No follow-up attempts are possible. No further information is expected.
A report from a health professional concerns a 33 year old female. No medical history, concurrent disease, or concomitant medication was provided except pregnancy status. On 14-Oct-2014, FLUMIST (intranasal) was administered to the patient who was a few weeks pregnant, and the patient miscarried. According to the company physician the event of patient miscarried was considered to be serious as an important medical event. According to the company physician the event of FLUMIST administered to a woman who is a few weeks pregnant upgraded to serious from non-serious as an important medical event. Follow-up information received by AstraZeneca/MedImmune on 20-Oct-2014 from a health professional upgraded this case to expeditable: New serious event added: patient miscarried. The seriousness of FLUMIST administered to a woman who is a few weeks pregnant changed from non-serious to serious. Pregnancy result updated. Details of the responsible physician added. Narrative update: Corrected Report on 28-Oct-2014. The patient's age at onset added. Start date of the event of FLUMIST administered to a woman who is a few weeks pregnant added. Start date of the suspect drug added. Details of administered by added.
Tips burning, lips swollen 4-5 mins after flu shot. Sent to ER Started on Predisone.
Pt received vaccine on 8/23/18- pt noticed 1 hive on 8/24/18-noticed increased hives on 8/27/18-pt felt weak and dizzy-had trouble swallowing-went to ER and was given epinephrine and prednisone-sent home with prednisone, BENADRYL and ZANTAC. Pt continued to have hives-seen in our office 8/29/18-went back into the ER 8/29/18 evening because of increased hives and trouble breathing-In ER was given BENADRYL and observed. Pt was sent home and continued with BENADRYL and tapering the prednisone. We drew labs for allergies when in our office 8/29-results positive for food allergies and referred to allergist.
ended up getting COVID; ended up getting COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Apr2021 (Lot number: EW0151, Expiration Date: 30Jul2021) at the age of 56 years as dose 2, single and administered in arm left, administration date 16Mar2021 (Lot number: EP7534, Expiration Date: 31Jul2021) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Verbatim: Blood pressure high; "Blood cholesterol" (unspecified if ongoing), notes: Verbatim: Cholesterol. Concomitant medication(s) included: VALSARTAN taken for hypertension; ROSUVASTATIN taken for blood cholesterol. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "ended up getting COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) getting covid, notes: I ended up getting COVID. Therapeutic measures were taken as a result of covid-19 with Azithromycin 250mg, that was for 5 days and it actually did help.The patient did not receive any other vaccines within four weeks prior to the vaccination.
Parent had self referred pt to Pharmacy for influenza vaccine on 9/28/10. Pt awoke 9/30/10 AM with urticarial rash and presented to clinic for assessment. (+) new food in last 24 hours (strawberries). No medications, no vaccines since 5/2010. Pt with concurrent URI predating influenza vaccine administration. Exam: congested, urticarial rash, no respiratory distress, lungs clear to auscultation cardiac status - stable.
PATIENT HAD A QUICK BLACK OUT AND WAS SWEATING PROFUSELY SHORT AFTER ADMINISTRATION FOLLOWING A WALK TO HIS SEAT
very gassy; loose BM [bowel movement]; bothersome stomach thing; This spontaneous case was reported by a consumer and describes the occurrence of FLATULENCE (very gassy), DIARRHOEA (loose BM [bowel movement]) and ABDOMINAL DISCOMFORT (bothersome stomach thing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced FLATULENCE (very gassy), DIARRHOEA (loose BM [bowel movement]) and ABDOMINAL DISCOMFORT (bothersome stomach thing). At the time of the report, FLATULENCE (very gassy), DIARRHOEA (loose BM [bowel movement]) and ABDOMINAL DISCOMFORT (bothersome stomach thing) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, Heart rate: fast heartbeat (High) fast heartbeat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter. Treatment information was not provided.
Two weeks post vax pt experienced fever. 15 days post vax pt developed a rash over hands, arms and legs.
has  test originally/she was exposed; has test originally/she was exposed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "has  test originally/she was exposed". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result. Additional information: Patient had  test originally in the mail the expiration date was 28Jan2023 (unspecified). Patient was wondering if she could still use it because she was exposed.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.