chrisvoncsefalvay/vaers-outcomes huggingface dataset:
went to dentist 18JUL94 lidocaine used for numbing; had MMR 19JUL94 & broke out in whelps on 23AUG93; went to PMD recvd Medrol dosepak; sx worse in PM; feet & hands swollen; p/3 wks sx are no better;
no appetite; not feeling good; stomach upset; No energy; My lymph nodes were swollen; chills; I was tired; shivering; headache; My arm was sore.; This is a spontaneous report from a contactable consumer. A 67-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955); via an unspecified route of administration in the left arm on 25Mar2021 (at the age 67-years) at 09:00 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. The patient had received other unspecified medications in two weeks of vaccination. The patient had previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198); via unspecified route of administration in the left arm on 04Mar2021 (at the age 67-year-old) at 14:00 as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 22:00, the patient experienced sore arm and swollen lymph nodes. The patient was tired and had headache, had chills so bad was shivering. The patient had no appetite and was not feeling good. The patient also experienced stomach upset, had no energy and was not hungry. The adverse 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 events. The clinical outcome of sore arm, swollen lymph nodes, stomach upset, chills, shivering, headache, tired, no appetite, not feeling good and no energy was recovered on an unknown date at the time of this report.    No follow-up attempts are needed. No further information is expected.
Pt had a temperature of 103.6 F. Pt also experienced seizure activity. Pt was seen in ER.
Thumping sensation in eye, behind calf, abdomen, arm; Nosebleed; Thumping sensation in eye, behind calf, abdomen, arm; Thumping sensation in eye, behind calf, abdomen, arm; Thumping sensation in eye, behind calf, abdomen, arm; This is a spontaneous report received 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: unknown) via an unknown route of administration in left arm on an unknown date in Mar2021 at 12:30 (at the age of 62-year-old), as single dose for COVID-19 immunisation. Medical history included hypertension and asthma. The patient was allergic to prednisone. Concomitant medications included unspecified blood pressure medication, iron pill and multi-vitamin. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On an unknown date in Mar2021 at 00:30, the patient experienced nosebleed and thumping sensation in eye, behind calf, abdomen and arm. The patient had not received treatment for the reported events. The events had resulted in the visit to the doctor or other healthcare professional office/clinic visit. The clinical outcome of the events nosebleed and thumping sensation in eye, behind calf, abdomen and arm was recovering at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
An attorney reported that a male pt received injections of Tetramune (diphtheria and tetanus toxoids and pertussis vaccine adsorbed and haemophilus b conjugate vaccine (diphtheria crm197 protein conjugate)), Flu Shield (1999-2000 formula), and Flu Shield (2000-2001 formula) vaccines as part of his childhood immunizations. It is alleged that, as a result of the toxicity from the thimerosal and the mercury and/or other heavy metal in the vaccines, he had the following symptoms: severe learning disabilities, impairments in social relatedness, language and communication difficulties, abnormal movements, sensory dysfunction, depressions, anxiety, hearing loss, severe bowel dysfunction, and other severe health disorders. The reporter also stated that the pt was exposed to heavy metals from emissions from a chemical plant. These events were considered medically important. No further info was available as of the date this was reported.
had a mild rash on her forehead and her chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (had a mild rash on her forehead and her chest) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 02-Mar-2021, the patient experienced RASH (had a mild rash on her forehead and her chest). At the time of the report, RASH (had a mild rash on her forehead and her chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information.
ACUTE RESPIRATORY FAILURE CHRONIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY 1/5/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Day 1 Nausea- 4 hrs after Swollen face/neck- 3 to 5 hrs- benadryl  Left eye extreme blurry  vision- 3 x's 2 to 5 min each Mental fog and confusion- 3 days intense, 4th day  trouble with recall without intense focus Headache- 3 days intense, 4th day- moderate Elevated heartrate- sporadic first day until 6 pm Highly irritable- 2 days Incessant talking and moving
throat swelled with blisters, could not talk; difficulty eating, drinking, swallowing  Doctor visit... given antibiotics
This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information about concurrent condition and historical medication. On 17-FEB-2016, the patient was inadvertently vaccinated with expired dose of ZOSTAVAX lot # K020185, expiration date- 27-JAN-2016, (expired product administered). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
Small, red, itchy rash on my abdomen; Itchy rash on my abdomen; This case was reported by a consumer via call center representative and described the occurrence of red rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced red rash and itchy rash. On an unknown date, the outcome of the red rash and itchy rash were unknown.   It was unknown if the reporter considered the red rash and itchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the dose of Shingrix and experienced small red, itchy rash on abdomen. The informaton regarding consent to follow up not reported. No further information was available.
Left leg erythematous, face pale, appeared unresponsive, within seconds the child responded, multiple macular eruptions present. Sent to the ED-WNL.
Per call from patient. Whole arm hot and red. Joint pain and stiff neck (11-8-12). Patient saw doctor, but doctor did not indicate if he thought it was related to vaccine.
This spontaneous report as received from a healthcare professional refers to unspecified number of patients of unknown age and gender. Since 11-NOV-2015 unspecified number of patients were vaccinated with GARDASIL (Lot# L007560, Expiry date: 15-JUN-2017, Lot# L013429, Expiry date: 21-JUL-2017 and Expiry date: 21-JUN-2017, Lot# L017407, Expiry date: 15-AUG-2017) which were exposed to temperatures outside of the recommended range (incorrect product storage). No adverse event were reported. This case is one of the several reports from the same reporter. Additional information has been requested.
Day #1, face tingling began at 3:00pm-10:00pm, localized redness and pain at injection site on right arm.  Day# 2,generalized body aches, headache, fever (101), face tingling all day,  pain and redness at injection site.   Day #3,  tiredness, face tingling  at 12:00PM-10:00PM, pain/swelling and redness at injection site.  Day#4,  slight cough with phlegm, and slight wheezing in morning and bedtime . pain/swelling/redness at injection site.   Day #5,  Slight wheezing  in  AM,  Pain, redness and edema at injection site and on the whole upper Right upper arm.
Patient received his first does of Moderna in the morning and presented to the emergency room with swollen testicles and a blocked urethra, unable to void.
& CELLULITIS  CEFTRIAXONE 2 GM EVERY DAY ,CEPHALEXIN 500 MG TID
7 days after vaccine developed redness, itchiness, and swelling around site of injection. This is still continuing at time of this report.
hives, difficult breathing, back pain, dysphonia. Being my husband an retired MD he gave me an injection of dexametazon 4 mg IM which improve my dysphonia and my breathing. I am taking anti allergy medicine : Loratadine  2 tablets and one of fexofenadrine and after an hour I feel better . I will go to the hospital if my signs and symptoms worsen.
Information has been received from a consumer concerning her 20 year old daughter with migraine and no drug reactions/allergies who in approximately June 2009 "approximately 3 months ago", was vaccinated with the first 0.5 mL dose of GARDASIL (lot # not reported). There was no concomitant medication. On 05-AUG-2009 the patient had a PAP test done which came back showing precancerous cell growth. At the time of the report, the patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Patient was given PROQUAD and KINRIX on 8/7/2015. Early morning 8/8/2015 he had an unwitnessed episode of syncope. He had what seems to be postictal period, and had ++polyps on diff, so was likely a seizure. Tmax 100.7 later in the day of 8/8/2015. 24 hours EEG nl; Echo/EKG nl.
Fatigue, nausea, dizziness, back pain, chills, faint feeling while working out. Happened very next day, stopped after 24 hours, then resumed.
Swollen lymph nodes in right breast; Feeling breast pain; Tenderness down part of arm, on the side; Tenderness in under arm/armpit; This is a spontaneous report from a contactable pharmacist, the patient. A 51-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 27Mar2021 at 13:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included mild asthma and Monosodium Glutamate (MSG) intolerance. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received type 1 antihistamines and experienced slight allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 17:30, 5 days after the vaccination, the patient experienced swollen lymph nodes in the right breast, axils and underarm and felt breast pain, tenderness under arm, down part of arm, on the side and in armpit. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events swollen lymph nodes in right breast, axils and underarm and felt breast pain, tenderness under arm, down part of arm, on the side and in armpit was resolving at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
BELLS PALSY- 6 days after the first dose I woke up with right side facial drooping and paralyzed nerves in my face. I was seen in the Emergency Room and was with medication, steroids for 4 days and anti viral medication for 7 days.
2/23/21 after 4 hours - fatigue, body ache 2/23/21 after 5 hours - EYEBALLS ached, shoulder and neck ache 2/24/21 woke to flu-like symptoms, chills, fever 99 to 102, fatigue  2/25/21 fever broke during the night.
tested positive for Covid; tested positive for Covid; Symptoms similar to sinus infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 46 year-old female patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Lot number: EL3248, Expiration Date: Apr2021) as dose 1, single and administration date 22Mar2021 (Lot number: EL3248, Expiration Date: Apr2021) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "tested positive for Covid", SINUSITIS (non-serious) with onset 2021, outcome "unknown", described as "Symptoms similar to sinus infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive.   No related quality issues were identified during the investigation.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected
Pt received varivax vaccine 03/23/2001. Pt came in the office with chicken pox disease 12/12/2005.
Information has been received from a consumer concerning her currently 43 year old daughter with a history of "had her gallbladder out, sinus problems and pneumonia" and allergic to codeine who at "sometimes in the 1990's was vaccinated with a dose of VARIVAX (Merck) (lot#, route and site of administration not reported). In the late 90's the patient developed shingles. She went to see her physician for treatment. Then again sometime in 2001-2003 the patient developed another shingles case. It was reported that the patient never had a history of chickenpox. She saw her physician for treatment and on an unspecified date she recovered. No further information is available.
This spontaneous report as received from a consumer refers to a male patient of unknown age reporting of himself. Pertinent medical history, drug reactions or allergies were not reported. On 05-MAY-2014, the patient was vaccinated with RECOMBIVAX HB dose 1 (route and lot # were not reported). On 05-AUG-2014, the patient was vaccinated with RECOMBIVAX HB dose 2 (route and lot # were not reported). The patient stated that this was outside the dosing schedule. No side effects reported. Additional information is not expected because the reporter details were not provided.
Pfizer booster shot; got infected with Covid; got infected with Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Pfizer booster shot"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got infected with Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: got infected with covid. Reporter reported that three of his friends had the Pfizer booster shot and got infected with Covid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101863869 same drug and patient, different event and drug dose;US-PFIZER_INC-202101863870 same drug and patient, different event and drug dose.
Information has been received from a physician concerning a 26 year old female who was vaccinated with the first dose of GARDASIL (route and lot number not reported).  The physician reported that " about 6 weeks ago", the patient developed cellulities on the right deltoid.  It was reported that the cellulities grew for two weeks so the patient was given an antibiotic (name and manufacturer unspecified) and the cellulites resolved (date unspecified)".  The patient sought unspecified medical attention.  Additional information has been requested.
Vaccine expired on 13 Oct 2021, vaccine placed in fridge on 18 Oct 2021; doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021, vaccine placed in fridge on 18 Oct 2021) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021, vaccine placed in fridge on 18 Oct 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021, vaccine placed in fridge on 18 Oct 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided  Date placed in refrigerator was 18 Oct 2021. There were no temperature excursions reported and patient did not experience any adverse events.  No treatment details were provided
Paxlovid taken from second day of Covid symptoms and positive test  23Sep - 27Sep; Paxlovid taken from second day of Covid symptoms and positive test  23Sep - 27Sep; Fully Vaccinated 2nd Pfizer 12Mar2021 Booster Pfizer 02Sep2021 Booster Moderna 31Mar2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 02Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Mar2022 at 09:00 as dose number unknown (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Paxlovid taken from second day of Covid symptoms and positive test  23Sep - 27Sep"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Fully Vaccinated 2nd Pfizer 12Mar2021 Booster Pfizer 02Sep2021 Booster Moderna 31Mar2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment; (2022) Positive, notes: Rebound infection testing positive and moderate to severe nasal drip; (23Sep2022) Positive, notes: positive test 243Sep -27Sep; (24Sep2022) Positive, notes: positive test 243Sep -27Sep; (25Sep2022) Positive, notes: positive test 243Sep -27Sep; (26Sep2022) Positive, notes: positive test 243Sep -27Sep; (27Sep2022) Positive, notes: positive test 243Sep -27Sep; (02Oct2022) Positive, notes: positive again 02Oct2022; (05Oct2022) Unknown result, notes: Nasal congestion and drip on going as of 05Oct2022. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Fully Vaccinated 2nd Pfizer 12Mar2021 Booster Pfizer  Booster Moderna 31Mar2022. The patient was given Paxlovid as treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Product Complaint; did not receive full dose; liquid shot out of the side of the syringe; This case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 10-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number NK45F, expiry date 30th June 2022) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd February 2022, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 23rd February 2022, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered and syringe leak. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the incomplete dose administered, syringe leak and pharmaceutical product complaint were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, they had 3 cracked prefilled syringes of the Fluarix.  The crack or breakage observed on the barrel of the syringe. The reporter stated that, she was administering Fluarix to the patient and once she injected into the patient's arm, the liquid shot out of the side of the syringe, which was cracked.  She stated that, the patient did not receive the full dose as it was wasted, which led to incomplete dose administered.  She claimed none of the medication touched the patient as it shot out into the air. She was unsure how much was leftover as the syringe was discarded.  They only had one of the syringes to return as the other was discarded. The defect was discovered on an unknown site. It was unknown if healthcare professional preparing or administering vaccine was a new or experienced use. It was unknown if the package or carton or blister tray damaged upon receipt. There was no any evidence of leakage or product in package or carton. The product was still present in the syringe at the time of reporting. Full demographics for patient was unavailable.  The reporter did not consent to follow up.