chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MEMBER WAS GIVEN INFLUENZA VACCINE AT 3:00PM, ON 30NOV22, AND STARTED HAVING HIVES AT ABOUT 3:45, MEMBER WAS SEEN AT THE LOCAL EMERGENCY ROOM FOR AN ADVERSE REACTION TO VACCINE, MEMBER WAS TREATED FOR AN ALLERGIC REACTION AND WAS RELEASED THE SAME DAY WITH OVERALL IMPROVED SYMPTOMS. PATIENT TREATED WITH ANTIHYSTAMINES AND STERIODS.
Since the second does of Pfeizer, the number of my menstrual cycles have increased and the pattern of menstruation has significantly changed. On three occasions, I have gotten two periods per month with distance of 10 to 15 days.  My normal  menstrual cycle is 28 days all my life.  Also the pattern of my periods were: 1 day of stain, followed by two to three days of moderate bleeding and another 2-3 days of stain.  Since the second dose of vaccine, my period starts abruptly with heavy bleeding and stays that way for the whole period. Currently, 7 months post vaccine, I am going through 10 days of moderate to heavy bleeding that is not stopping.
This spontaneous report was received from a medical assistant and refers to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 26-MAR-2018, the patient was vaccinated with ZOSTAVAX lot number N025567 with expiration date on 13-DEC-2018, subcutaneous for prophylaxis (strength, dose and anatomical location were not reported). It was reported that during the vaccine administration process, when the nurse pulled the needle out of the patient, some of the ZOSTAVAX went on the patient's face and into the patient's eye. No adverse effects were reported.
Fever; This is a spontaneous report from a contactable consumer via a female patient of an unspecified age received first dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical and concomitant medications were not reported. On an unspecified date the transferring agent stated, I have a patient on the other line the reason for the transfer is she would like to know if she can take Tylenol or blood pressure pills (Further clarification unknown hence not captured in tab) after the vaccine, the reason why the transfer is she had a fever after the 1st dose of Pfizer Covid-19 vaccine. When asked is there anything you want to add, the transferring agent stated, He disconnected So, I gave you the information. The outcome of the event was unknown.  Information about lot/batch number is requested.
hx of metastatic ovarian CA, DMT2; admitted with poor oral intake, N/V, acute renal failure on chronic kidney disease, esophageal dysphagia; positive test for COVID, asymptomatic; poor prognosis; DNR; experienced hypoxia and hypotension; sudden asystole and pt passed away in the hospital
Body aches.; sweating; chills; lethargy; headache; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 29Mar2021 at 12:45 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food, or other products. Concomitant medications included rosuvastatin calcium (CRESTOR), guanfacine (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN) for unknown indication from unknown dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 16:30, the patient experienced body aches, sweating, chills, lethargy and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatments were not taken as a result of the adverse events. The clinical outcome of the events body aches, sweating, chills, lethargy and headache was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Presented to hospital on 2/26 with worsening shortness of breath. Recently tested positive for covid and influenza A and B in January. Had been prviously hospitalized 2/15-16 for bilateral pulmonaty emboli for whihc she was discharged on eliquis and O2 at 1 L per NC.  Fever 103 and requiring 4 L O2. Chest xray showed recent emboli resolved but worsening mutifocal pneumonia. Started on heparin drip then transitioned to argatroban due to thrombocytopenia. Started vancomycin and cefepime. On 3/2  had increased confusion and difficulty speaking with CT head showing multiple subacute infarcts. Transferred to ICU where was intubated and place on ventilatory support. Added zosyn, doxycycline and cresemba. All cultures and stains were negative. Family decided to change code status to DNR/DNI and she was extubated on 3/8. Unable to speak. Anitbioitic discontinued and increasing O2 requiremtns were needed. EKG showed NSTEMI and cardiology started beta blocker and nitroglycerin drip. On 3/10 patient and family decided to stop all treatment.
fluzone quad a patient should receive if the syringe needle was pulled out before the vaccine was all able to be injected and the rest "spritzed out everywhere with no reported adverse event; fluzone quad administered to a 67 years patient with no reported adverse event; Initial information received on 02-Oct-2023 regarding an unsolicited valid non-serious case received from a Physician.  This case involves a 67 years old male patient who was administered Influenza quadrival a-b vaccine [Fluzone QIV] with no reported adverse event and patient receive if the syringe needle was pulled out before the vaccine was all able to be injected and the rest "spritzed out everywhere with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 02-Oct-2023, the patient received 0.5 ml dose of suspect influenza quadrival a-b vaccine Suspension for injection (lot UG809MA) via intramuscular route in the right deltoid (strength and expiration date: not provided) for Immunisation (incorrect dose administered) (product administered to patient of inappropriate age) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the 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 the 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.
Watering in mouth; Medicinal taste that covered tongue; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 01Mar2021 at 13:00 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no allergies to medications, food, or other products. Prior to the 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 medications included vitamin d (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL) from an unknown date and for an unknown indication. On 01Mar2021 at 13:15, 15 minutes after the vaccination, the patient experienced watering in mouth and then a medicinal taste that covered her tongue. It lasted approximately 15 hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events watering in mouth and medicinal taste that covered tongue were resolved on 02Mar2021 at 04:15, after the duration of 15 hours.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
The incident occurred at a public health department school based H1N1 clinic on XX/XX/2009. There were several presentations of vaccine available to give. Some younger preschool program children were present at the clinic without their parents. A volunteer RN inadvertently gave a Novartis (>4 yr old) 0.5 ml injectable H1N1 vaccine to a child (<4yrs old) the error was discovered immediately by fellow nurses. The medical director of the health dept was notified of the error. The mother of the child was also notified.
Full body rash (scattered over arms/trunk/legs).    Unclear if due to vaccine, but figured would report... (Note: child has not had a rash in the prior ?6-7? years)
Fever and extreme body aches and body weakness for over 14 hours. Was more intense than described in all information shared. Thought about taking myself to the ER but decided to wait it out. I am not one to get concerned but the feeling was so intense that I was very concerned.
paraesthesia, tingling and pins and needles, feeling in both feet that has continued since; Heaviness in her legs; Fatigue; Headache; Dry mouth; Soreness in right arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 23Sep2021 12:45 (Lot number: EW0172, Expiration Date: 30Nov2021) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PARAESTHESIA (non-serious) with onset 24Sep2021 16:00, outcome "recovered" (2021), described as "paraesthesia, tingling and pins and needles, feeling in both feet that has continued since"; LIMB DISCOMFORT (non-serious) with onset 24Sep2021 16:00, outcome "recovered" (2021), described as "Heaviness in her legs"; FATIGUE (non-serious) with onset 24Sep2021 16:00, outcome "unknown", described as "Fatigue"; HEADACHE (non-serious) with onset 24Sep2021 16:00, outcome "unknown", described as "Headache"; DRY MOUTH (non-serious) with onset 24Sep2021 16:00, outcome "unknown", described as "Dry mouth"; PAIN IN EXTREMITY (non-serious) with onset 24Sep2021 16:00, outcome "unknown", described as "Soreness in right arm". The events "paraesthesia, tingling and pins and needles, feeling in both feet that has continued since", "heaviness in her legs", "fatigue", "headache", "dry mouth" and "soreness in right arm" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of paraesthesia, limb discomfort, fatigue, headache, dry mouth, pain in extremity.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not Known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient called on 28Sep2021, started that experienced an unusual adverse reaction from the Pfizer BioNTech Covid-19 Vaccine. Received Vaccine on 23Sep2021. On 24Sep2021, the patient experienced fatigue, headache, dry mouth, and soreness in right arm. She had those during the day and then she had the others later at night. Later in day on 24Sep2021, the patient was most concerned about paraesthesia, tingling and pins and needles, feeling in both feet that has continued since, plus a heavy feeling in both legs. She was going to see primary care physician on 29Sep2021. The patient called back in Nov to say she  had recovered but the patient did not know what treatment her PCP provided and how long it took to recover.  No follow-up attempts are possible. No further information is expected.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (Pregnant) in a 38-year-old female patient (gravida 4, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was in August 2020 and the estimated date of delivery was 23-Jun-2021. On an unknown date, the patient experienced PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, PREGNANCY (Pregnant) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Fever of 101.6 in the afternoon on the first day after, also chills, headache.
The child developed a red raised linear pustule rash and a knot at the injection site (Left thigh) of the Varicella injection. The parent did not report any fever or sickness other than the above rash.
Injection site soreness starting about 4 hours after injection (around 6:00pm) and lasting through the end of the following day. Body aches,  soreness, and head fogginess   starting at the beginning of the following day (4/15/2021) and lasting the entire day. Tylenol was taken multiple times for soreness and did slightly reduce soreness for a few hours.
Arm soreness; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm soreness"; FATIGUE (non-serious), outcome "unknown", described as "Tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3 hours after receipt of AVA#1 pt pt had nausea, general body aches and he felt feverish. Temp not taken. Symptoms worsened over next 24 hours. Pt did not eat, drink and take anything for sx. The next day pt also noted cyanotic hands and lips. Within 24 hours all symptoms subsided.
Case number PHEH2012US015123 is an initial spontaneous report received from a pharmacist on 31 Jul 2012. This case refers to a 30-year-old female patient. She was vaccinated with MENVEO vaccine (batch number: A10047) intramuscularly on 31 Jul 2012. It was reported that MenA lyophilized conjugate component of MENVEO was reconstituted with sterile water instead of being reconstituted with MenCYW liquid conjugate component of MENVEO. No adverse event was reported following vaccination.
Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 62-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 25-JAN-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 14-APR-2023 The Shingles vaccine temperature excursion was exposed and patient received unstable vaccine, which led to incorrect storage of drug. This case was 1 of 169 cases for the patient reported by same reporter. The reporter did consent to follow up. This case had been linked with US2023054677 and US2023AMR055743 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
The day of the vaccine was fine.  The next day the arm hurt in that area, sore for only 1 day.  Was fine until 1/26/21, while showing noticed a red mark patch around the vaccinated area, iced it a few times.  She got alarmed and called her doctor who told her to go to the UC which she did who told her that it might be a reaction to the vaccine.  Did not prescribe anything, did not tell her anything.  No temp, etc.  Started Benadryl took 2 the first night, and then took on 1/27/21 took three, morning, noon or evening.  It was not as red then 1/26/21.   Hurts a little today, sore around the area.  Not red anymore.
The doctor was called STAT to evaluate this patient who was having feelings of weakness and feeling faint in the observation area after she received her first Pfizer COVID vaccine yesterday morning at the vaccination cite. She had already been given an IM Epi Pen injection of epi by the PA prior to my arrival.  I had her lie supine with head down and legs elevated and she felt better.  She declined EMS transport to ER.  Further talk with her dad revealed she had been up since 2 am and had no breakfast.  I don't think an allergy.
I am the epidemiologist reporting on behalf of 71-year-old male patient. The patient received two doses of the Pfizer vaccine on 3/3/21 and 3/25/21. The patient initially tested positive for COVID via a PCR test on 3/27/21 (two days after second dose) and again on 4/21/21. Patient was in ICU, on a Vent 4/2/21 until 4/25/21; Covid pneumonia, hypoxia, completed Remdesivir, patient had an arterial thrombosis LLE required a thrombectomy and fasciotomy on 4/4/21. Patient expired on 4/25/21 (one month after receiving second dose of Pfizer vaccine). Cause of death is listed as multiorgan failure secondary to COVID-19, ventilator dependent respiratory failure and ARDS. Other significant conditions contributing to death but not resulting in underlying cause are thrombocytopenia, anemia, right MCA infarct-subacute. I am reporting this to VAERS now because vaccination status was not considered at the time of the report.
Narrative:  COVID infection with hospitalization following COVID vaccine 03/18/21 COVID positive 05/21/21 COVID vaccine dose #1 of 1 08/19/21 Pt hospitalized with c/o lower extremity weakness, vision changes, dizziness; reports typical of MS flares 08/22/21 Discharged from hospital 01/27/22 Seen in ED c/o worsening cough, shortness of breath (worsening since 11/21), found to be COVID positive, discharged home 02/02/22 Pt admitted through ED c/o worsening non-productive cough, fever, chills, bodyaches, right sided chest pain, severe shortness of breath; found to have bilateral PEs & multifocal PNA 02/08/22 Discharged from hospital on apixaban
Body ache; pain in arm from the vaccine; fever; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported same events for two patients. This is 2nd of two reports. A male patient started to receive BNT162B2 on 18Dec2020 (reported as yesterday, as of 19Dec2020) at single dose for covid-19 immunisation. Medical history, concomitant medications or past drug history were not provided. He experienced body ache, pain in arm from the vaccine and fever in Dec2020. Outcome of the events was unknown.   Information about lot/batch number has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020506072 Same reporter/ drug/ event for different patients.
Patient came in requesting second booster of pfizer covid 19 vaccination.  After filling out consent form a 0.3mL IM dose was administered in left arm (upper deltoid).  Upon later review of rx records it became evident that the patient was not the required 50 years of age to have received the second booster.  No adverse reactions occurred.
She couldn't walk without holding onto something & couldn't read or watch tv; severe dizziness so bad that she couldn't drive or do anything; This spontaneous case was reported by a consumer and describes the occurrence of DYSKINESIA (She couldn't walk without holding onto something & couldn't read or watch tv) and DIZZINESS (severe dizziness so bad that she couldn't drive or do anything) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus and Overweight.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced DYSKINESIA (She couldn't walk without holding onto something & couldn't read or watch tv) and DIZZINESS (severe dizziness so bad that she couldn't drive or do anything). At the time of the report, DYSKINESIA (She couldn't walk without holding onto something & couldn't read or watch tv) outcome was unknown and DIZZINESS (severe dizziness so bad that she couldn't drive or do anything) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) negative for benign positional vertigo and MS (MRI was normal).         Concomitant medication of the patient was not reported.   The patient began seeing a neurological specialist who tested her for benign positional vertigo and MS; including an MRI. The dizziness finally went away after 8 months. The events never did affect her strength.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-408514 .