chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received expired dose of Flublok Quadrivalent with no AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA316777, 2019SA316754 and 2019SA316760.  This case involves a 77 years old male patient who received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA1824, expiry date: 30-Jun-2019) via unknown route on 06-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.   At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Itchy rash on neck the next am. Lasted for 12 days- no Tx to it. Now resolved. no temperature
Body chills; low grade fever (99.8-100.8); mild headache; malaise; approximately 3 inch circular, hard, red and warm to touch area at injection site.  Area painful.
pt recv vax; fever 103; hard, red to brown,hot; 3" diam area rt upper arm starting on 10jul95; saw MD on 11jul95; tx w/ dph;
about 3 minutes after receiving vaccine, heart rate jumped to extremely high.  Patient did not report until today so we were not able to get actual heart rate.  This lasted for about 30 seconds, then went back to normal.
patient experienced redness,swelling,rash and severe burning sensation at the injection site immediately and  Patient is stating she has not gotten better and now she is also experiencing joint pain.
PATIENT CAME IN AND FILLED OUT A VOUCHER CONFIRMING HE HAD NO PREVIOUS COVID VACCINES. UPON ENTERING JANSSEN VACCINE INTO COMPUTER, WE NOTICED THAT HE HAD ALREADY RECEIVED BOTH DOSES OF HIS PFIZER VACCINE.
5 days after first injection lymph node in left arm became swollen.  days later tenderness and swelling started traveling down my arm.   day after second injection. lymph node became larger, entire arm more painful and swollen, and vein's all the way down to wrist was swollen, painful, and felt like a rubber band being stretched.  could not lift up my arm.  first was diagnosed with Lymphadenitis and was prescribed amoxicillin.  days after kept getting worse so put on Bactrim for 2 weeks and was sent for an MRI of my arm for possible blood clot in arm.  No clot detected .  Today arm better, still have a small lump under arm and still feed some tightness/pulling/burning in my left arm.
This is a spontaneous report received from contactable consumer or other non-HCP (patient). A 74-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EL9261), at the age of 72, left arm, on Jan 26, 2021, single dose, for COVID-19 immunization. Medical history included blood pressure (unspecified if ongoing) and allergy (unspecified if ongoing). Concomitant medication included hydrochlorothiazide taken for blood pressure measurement. The patient experienced flushing/she had minor face flushing, with outcome of unknown. No therapeutic measures taken as a result of flushing. Additional information: Patient said her age was 73 and 74 when events occurred. Patient received other medication included Wixela for allergy. She had minor face flushing like an allergy, but it was not significant and not reportable. Patient received dose 2 on Feb 16, 2021 and dose 3 on Nov 19, 2021. The rest of her symptoms occurred immediately after booster and persisted for 6-7 weeks. She would like to know if she risks getting another booster or not. Caller declined to provide batch/lot numbers for her first, second and third doses of the vaccine. She said she has heart damage and is exhausted. The information on the batch/lot number for BNT162B2 requested and will be submitted if/when received.
Arthritis flare in upper mid back and neck; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0173) via an unspecified route of administration in the left arm on 05May2021 at 08:45 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included arthritis, polycystic ovarian syndrome (PCOS) and allergy to sulfa. The patient previously received fluconazole (MANUFACTURER UNKNOWN) and ciprofloxacin (CIPRO) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included too many supplements (unspecified) for unknown indications, from unknown start dates and unknown if on going. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0153) via an unspecified route of administration in the left arm on 07Apr2021 at 08:45 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. On 07May2021 at 10:00, on the third day after COVID shot, the patient experienced arthritis flare in upper mid back and neck. The patient was not on any immunosuppressive therapy or particular treatment plan for arthritis, but she suffered from flares for nearly 10 years for unknown reasons despite thorough testing. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the event. The clinical outcome of the event arthritis flare in upper mid back and neck was unknown at the time of report.  No follow-up attempts are needed. No further information is expected.
Ocular Herpes in Left eye, Fever, Nausea, Slight headache, Body aches x's 1 1/2 days.
This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age and gender. On 16-APR-2015, the patient was vaccinated with one dose of PROQUAD (Merck) that had been improperly stored (subcutaneous, lot # K025760, expiry: 08-JUN-2016, dose not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a healthcare worker refers to a 18 year old female patient with no pertinent medical history and no drug reactions or allergies. On an unspecified dates the patient received three doses of GARDASIL injection (lot number, doses, routes and sites of administration were not reported). Concomitant therapies included ORTHO TRI-CYCLEN. On 30-JUL-2013 the patient went to her physician's office for routine visit and her pap smear resulted high risk positive on an unspecified HPV type. There was no treatment given for the adverse event. The patient sought medical attention. The patient did not recover from the adverse event. The relatedness between therapy with GARDASIL and adverse event was not reported. Additional information has been requested.
2000 hrs Wife became nausea,  vomiting, chills, body aching, headache, etc. Spiked temperature 102.5 in less than 24 hrs.
First period after vaccine was very. very heavy! I was sent to the ER due to big clots and significant blood loss. Period started a week early on 4/22 and is still going on. Usually done within 5 days and not nearly as heavy with clots like this. ER suggested I report a possible correlation between that and the vaccine as they have seen it with other patients as well. ER doctor medicated with birth control hormones to slow down bleeding.
Information has been received from a licensed visiting nurse (LVN) concerning a 15 year old female with allergic rhinitis and a history of headache and meningitis (at 7 years of age) who on 25-MAR-2008 (Lot 659657/1487U), 10-JUN-2008 and 24-JUN-2008 (Lot #660391/0063X) was vaccinated IM with 0.5 mL doses of GARDASIL vaccine (yeast). Concomitant therapy included mometasone furoate (NASONEX). On 24-JUN-2008, after vaccination, the patient became dizzy/lightheaded upon standing and also developed a headache. The patient was treated with ibuprofen (MOTRIN) 800 mg for the headache. The patient did not require hospitalization, but was seen in the office. At the time of this report, the patient's dizziness/lightheadedness and headache persisted. Additional information has been requested.
Patient reported a splotchy/itchy rash covering the chest and neck starting two days post vaccine on 4/2/21.  The rash has started to resolve but is still present at time of report on 4/15/21.  Patient did not report adverse effect until 4/15/21.
high blood pressure; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 42 years 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: BLOOD PRESSURE INCREASED (medically significant), outcome "unknown", described as "high blood pressure". The patient underwent the following laboratory tests and procedures: blood pressure measurement: 188/119 and 170/120.  Clinical Course: A female animal technician said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine 2 weeks ago, and scheduled to receive the 2nd dose on Thursday. She said she never had a high blood pressure, but ever since she took the 1st dose of the vaccine, her blood pressure rose up to 188/119 and 170/120. She wanted to know what would happen if she does not receive the 2nd dose and if it would be dangerous.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event and the use of suspect product BNT162B2 cannot be fully 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
Dizziness, Headache, Arthralgia & NauseaVomiting Narrative:
blood under the bandage.; sore arm; A spontaneous report was received from a consumer concerning a 60-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, blood underneath bandage.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 1 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On 1 Mar 2021, the patient experienced the event(s) sore arm, blood underneath bandage.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, blood underneath bandage was unknown.
Fully vaccinated and boosted times one.   37 gestation vaginal delivery Baby Male-(baby not named at time of discharge)  DOB 9.11.22
Twice the first night I lost bladder control. Today I have sores inside my lower lip. Not serious but not a mention of the possibilities
An hour or so after injection pt became very dizzy and disoriented and a very fast pounding heart with sharp pains,heart palpitations and extreme fatigue and increased these symptoms with exersice. This has continued for a month now.
Severe pain, limited range of motion, rash, redness, warmth, low grade fever, swelling.
Pt is reporting a 4" long and 3/4 " wide red streak at injection site not hot or bothersome just there not streaking towards heart  Was advised to call back or contact physician if symptoms worsen.
Information has been received from a consumer concerning her 16 year old daughter with no medical history and no drug reactions/allergies, who on 06-Nov-2007 was vaccinated with first dose of GARDASIL vaccine (yeast) (lot# unspecified). On 11-Jun-2008, the patient was vaccinated with 0.5ml of second dose of GARDASIL vaccine (yeast) (lot# unspecified). It was reported that "about 12 hours after vaccination", the patient experienced rash on her arms and face. There was no concomitant medication. It was also reported that the patient had no ill effects after vaccination with her first dose of GARDASIL vaccine (yeast). Unspecified medical attention was sought by calling physician. At the time of this report the patient was still recovering from her experiences. Additional information has been requested.
I had the SHINGRIX vaccine on Tuesday, Jan, 30, was told side effects were confined to the injection site: For two days I felt like I had the flu, with headache, achiness, fatigue, sleepiness.
While onboarding a new team member who was 17 years old Moderna was administered when she should have received Pfizer.
Patient received one dose of Janssen from a vial that was opened for 6 hours and 23 minutes causing the dose to be expired by 23 minutes at the time the patient received it. Vaccine vial and dose was maintained in cooler between 2 degrees and 8 degrees Celsius prior administration.  Patient experienced no adverse reactions.
Her son missed the second dose of GARDASIL 9 two months later, because of school activities and sports. And had not been able to get the second dose because of pandemic restrictions.; This spontaneous report was received from the patient's mother referring to her 17 year old male son. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.     In August 2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown)  for prophylaxis.   The patient´s mother reported that her son missed the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) two months later (approximatly October 2019), because of school activities and sports. And  that her son had not been able to get the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) because of pandemic restrictions.
Tested positive for covid-19; Tiredness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for covid-19) and FATIGUE (Tiredness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced FATIGUE (Tiredness). On 25-Jan-2021, the patient experienced COVID-19 (Tested positive for covid-19). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event NOS, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for covid-19) and FATIGUE (Tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, SARS-CoV-2 test: positive (Positive) Other.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
Burning sensation on both of her legs; Statis dermatitis; Agitated; Infection leg; arm soreness; Excruciating pain on both legs; Arm soreness at the injection site; Extreme edema in both legs; Triggered Manic episodes; Lupus flare up; Arthritis flare up; Swelling of both legs; This spontaneous case was reported by a patient and describes the occurrence of SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Psoriasis, Cellulitis and Intra-cerebral aneurysm clipping since an unknown date. Concurrent medical conditions included Drug allergy (Allergy to Methothrexate.), Drug allergy (Allergy to Prednisone.), Drug allergy (Allergy to Peroxide  (topical).), Hepatitis B carrier and Bipolar disorder.    On 07-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up) (seriousness criterion medically significant), ARTHRITIS (Arthritis flare up), PERIPHERAL SWELLING (Swelling of both legs), OEDEMA PERIPHERAL (Extreme edema in both legs), MANIA (Triggered Manic episodes), PAIN IN EXTREMITY (Excruciating pain on both legs) and VACCINATION SITE PAIN (Arm soreness at the injection site). On an unknown date, the patient experienced BURNING SENSATION (Burning sensation on both of her legs), STASIS DERMATITIS (Statis dermatitis), AGITATION (Agitated), LOCALISED INFECTION (Infection leg) and PAIN IN EXTREMITY (arm soreness). The patient was treated with AMOXICILLIN at an unspecified dose and frequency and TRAMADOL at an unspecified dose and frequency. On 09-Jul-2021, VACCINATION SITE PAIN (Arm soreness at the injection site) had resolved. At the time of the report, SYSTEMIC LUPUS ERYTHEMATOSUS (Lupus flare up), ARTHRITIS (Arthritis flare up), PERIPHERAL SWELLING (Swelling of both legs), BURNING SENSATION (Burning sensation on both of her legs), OEDEMA PERIPHERAL (Extreme edema in both legs), AGITATION (Agitated), LOCALISED INFECTION (Infection leg), PAIN IN EXTREMITY (Excruciating pain on both legs) and PAIN IN EXTREMITY (arm soreness) outcome was unknown and MANIA (Triggered Manic episodes) and STASIS DERMATITIS (Statis dermatitis) had not 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.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Binocular double vision (with both eyes open) began the day after the booster following more typical body aches and a headache behind left eye. Double vision made it difficult to function ? had to shut one eye to read, for example. The condition began to clear up in about two months and had completely disappeared after about three months.
Information has been received from a physician concerning a 17 year old female who was vaccinated on an unspecified date with GARDASIL (lot# not provided). Concomitant therapy included MENACTRA and poliovirus vaccine. Subsequently the patient fainted after receiving the vaccines. When she came to she had a "conversion reaction" where she was anxious, shaky and hyperactive. The patient was taken to the ER, but was not admitted. Subsequently, the patient recovered from fainting, being anxious, shaky and hyperactive. Additional information has been requested.
Patient had flu like symptoms over night after receiving her second shingrix vaccination. Including chills, body aches, and headache.
Her injected arm is swollen. She had high temperature at night. She saw the Dr next day. She was given cephalexin to take by mouth.
First menstrual period after the vaccine has been full of the worst pain/have cramped intensely for several days; This is a spontaneous report from a contactable nurse. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the left arm on 22Jul2021 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to nickel. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication was reported as not applicable (as per source document). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FW0181) via an unspecified route of administration in the left arm on 30Jun2021 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. On 12Sep2021, the patient experienced her first menstrual period after the vaccine had been full of the worst pain, the patient have had since she started her period 12 years ago. The patient had cramped intensely for several days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event first menstrual period after the vaccine has been full of the worst pain/have cramped intensely for several days was recovering at the time of this report.
Blood pressure roller coaster over 3 days: highest 148/84 down to lowest 105/85; chills, pain in upper left quadrant chest on 3rd day, vision  issue and pressure behind left eye after 5 minutes--pressure lasted for 3 days with different levels of pressure; chills, dripping nose on day 1, and itchiness on both arms especially around elbows--has continued