chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician via sales rep and described the occurrence of injection site pain in a unspecified number of infant patients who received PEDIARIX for prophylaxis. On an unknown date, the patient received PEDIARIX at an unknown dose. On an unknown date, unknown after receiving PEDIARIX, the patients experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to PEDIARIX. Additional details were not not provided as follows: The age at vaccination was not provided for the patients. The physician stated that, generally infants seems to experienced injection site pain with PEDIARIX.
Patient had a vasovagal type of reaction  Patient briefly blacked out and then came to a couple seconds later about 3 minutes after the vaccine was administered. After coming to, patient was shaking and profusely sweating until ambulance arrived and checked vitals
Lymph nodes in my groining, armpits, chest and back of my head are swollen and painful. Has been going on since March 21
This spontaneous report was received from a physician referring about a 1 year old female patient. Medical history and concurrent diseases were not reported. On 02-JUL-2013, the patient was vaccinated with PROQUAD (Merck) lot # J002307, expiration date 22-AUG-2014, 0.5 ml, subcutaneous, also reported as "one year birthday". Co-suspect and secondary therapies were not reported. On 13-NOV-2013, the physician reports that patient received PROQUAD (Merck) and had an outbreak of shingles, 135 days after onset of therapy. On 04-DEC-2013, the patient recovered with minimum scarring. The patient did seek medical attention at the office visit and she was treated with ACYCLOVIR. Lab diagnostics studies performed were herpes titers and varicella titers, and they were referred to an unspecified dermatologist to confirm shingles. No results provided. Causality was not provided at the time of the report. Additional information has been requested.
OUT OF SPECIFICATION PRODUCT USE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned a 39 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 20-DEC-2021) dose was not reported, administered on 22-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, the patient experienced incorrect product storage. On 22-NOV-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and incorrect product storage was not reported. This report was non-serious.
Fever/(100 degrees F); achiness; chills; fatigue; swollen lymph nodes under arm and in collar bone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Oct2021 14:00 (Lot number: FF2589) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allrgy: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: BLISOVI 24 FE; ADVIL [IBUPROFEN]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Vaccine Administration Time: 10:30 AM, Route of Administration: Intramuscular), administration date: 04Mar2021, when the patient was 42 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Vaccine Administration Time: 10:30 AM, Route of Administration: Intramuscular), administration date: 25Mar2021, when the patient was 42 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 13Oct2021 02:30, outcome "recovered" (15Oct2021 02:30), described as "Fever/(100 degrees F)"; PAIN (non-serious) with onset 13Oct2021 02:30, outcome "recovered" (15Oct2021 02:30), described as "achiness"; CHILLS (non-serious) with onset 13Oct2021 02:30, outcome "recovered" (15Oct2021 02:30), described as "chills"; FATIGUE (non-serious) with onset 13Oct2021 02:30, outcome "recovered" (15Oct2021 02:30), described as "fatigue"; LYMPHADENOPATHY (non-serious) with onset 13Oct2021 02:30, outcome "not recovered", described as "swollen lymph nodes under arm and in collar bone". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, pain, chills, fatigue, lymphadenopathy. Additional information: Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No other vaccine in four weeks. No follow-up attempts are possible. No further information is expected.
Patient experience chills; shivering and injection site swelling.  This lasted 3 hours.
Nausea; Soreness at the injection site; Dizziness; Headache; Lymphadenopathy under the arm andon neck near collar bone (on the rightside); This is a spontaneous report received from a contactable consumer, the patient. A 51-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no: EL3247), via an unspecified route of administration in the right arm on 15Mar2021 02:00 PM (at the age of 51-years-old) as a single dose for COVID-19 vaccination. Medical history included penicillin allergy. The patient did not have any allergies to food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient past drug history included BNT162B2 (BNT162B2 Lot/batch no: EL3247), dose number 1 via an unspecified route of administration in the right arm on 22Feb2021 at 02:00 PM as single dose for COVID-19 immunization. On 16Mar2021 at 02:00 AM, the patient experienced Headache, Nausea, Dizziness, Soreness at the injection site, Lymphadenopathy under the arm and on neck near collar bone (on the right side). No therapeutic measures were taken for the event. The clinical outcome of the event Headache, Nausea, Dizziness, Soreness at the injection site, Lymphadenopathy was recovering at the time of the report. No follow-up attempts are needed. No further information is expected.
Pt. given vaccine in R deltoid, area had small amount of swelling & warm to touch.
On 12/24, at 8:30a I began to get nauseated  which lasted about 2hrs. Around 1am I woke  up with SOB which continued thru the night, with off and on sleep. I woke back up at 5:45am, went to work with the SOB which lasted until 12N and resolved on its own.  Around 3-330pm I began to feel feverish and had chills and was told I was disoriented.  My temp was 100.5, HR 122 R 34 BP 170/100 O2-93%. I notified the DON of my feelings who advised me those were possible side effects of the vaccine and made me continue to work until I just couldnt take the feelings anymore and went to the ER.  I was there for about 2 hrs and my body began to calm down.  I took taken 100mg of Tylenol on my own just to help with the fever which did break shortly and I have been fine every since. I was positive for COVID 12/14.
Breakthrough case of SARS-CoV2. 26OCt2021; Breakthrough case of SARS-CoV2. 26Oct2021; This is a spontaneous report from a contactable consumer (patient). A 46-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 intramuscular, administered in Arm Right on 17Feb2021 (at the age of 46-years-old) (Batch/Lot Number: EN5318) as DOSE 2, SINGLE, dose 1 intramuscular, administered in Arm Right on 27Jan2021 (Batch/Lot Number: EN5318) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced breakthrough case of sars-cov2 (vaccination failure) on 26Oct2021 20:00. The patient underwent lab tests and procedures which included rapid COVID-19 Antigen test (Nasal Swab) was positive on 26Oct2021. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any treatment for adverse event. Prior vaccination patient did not tested for covid. Seriousness of event was reported as non serious by the reporter. Outcome of event was unknown.   Follow-up attempts are completed. No further information is expected.
Swollen lymph nodes in armpit on side of body where got the shot. Sore arm
PREVNAR 13. The patient developed MRSA pneumonia within 1 month of the vaccine. He is the 1st of 4 cases I am submitting with the same complication (others not MRSA).
Site where vaccine given is red, swollen and tender. 10 x 15 cm.
large local rxn w/redness & swelling of lt arm beginning 7APR95 exp discomfort inj site to elbow; seen by MD 11APR95 & prescribed Duricef;
This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with one dose of M-M-R II (dose, administration route, lot number and expiration date were not provided). No concomitant therapies were reported. The reporting Nurse stated that on an unspecified date the administered vaccine underwent a supported temperature excursion. No adverse effects were reported. This is one of several reports from the same patient. Additional information has been requested.
ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 22 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 08-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-OCT-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211017536, 20211017111 and 20211017116.
Information has been received from a nurse concerning her 12 year old daughter who on 08-AUG-2007 was vaccinated intramuscularly with the 1st dose of Gardasil (Lot# 658488/0930U). Concomitant therapies included an unspecified varicella and hepatitis A vaccinations. The patient's mother stated that after the vaccinations the girl was "feeling fine" and went into the bathroom, fainted and hit her face on the tile floor. The mother reported that the patient was rushed into emergency oral surgery. She reported that the patient has undergone root canal and now has braces. It was reported that the patient does not have a history of fainting after injections. Follow up information received from the patient's physicians office stated that the patient was "not hospitalized, just visited the oral surgeon to have her teeth re implanted". It was reported that the events were not disabling. It was reported that the patient was fine, got up to go the bathroom and fainted in the bathroom. At the time of the report the patient had recovered from the events. Upon internal medical review the oral trauma was felt to be an other important medical event. Additional information has been requested.
This is one case out of a cumulative total of 219 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 01 November 2013. These 219 cases represent children who received 3 or more doses of Sanofi Pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 01 November 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 2-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 4 doses of DAPTACEL; lot number C3449BA received on 12 April 2011, lot number C3449AA received on 10 June 2011, lot number 12 August 2011 and lot number C4022AA received on 24 August 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms on 02 October 2013, approximately 13 months after the last dose. On 02 October 2013, the subject developed a cough and paroxysmal cough on 08 October 2013 without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 04 October 2013 for 5 days. The subject was not hospitalized. At the time of final contact on 21 October 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 19 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Soreness in arm beginning the afternoon vaccine was administered and lasting  approx 56 hours, fatigue beginning in the late afternoon and lasting  approx 36 hours, urticaria developed bilaterally on the medial elbows beginning overnight Tuesday into Wednesday morning.  The urticaria is now drying out and beginning to heal but is still present.  No intervention was sought from a medical provider.  It is mild and no treatment was needed.
Problems lifting her right arm/now is hurting again; Problems lifting her right arm/now is hurting again; This spontaneous case was received on 20-Oct-2020 from other health professional (nurse) via Health Authority (reference number: SEQW20-03968) and concerned a female patient of unspecified age.  The patient's medical history and concomitant medications were not reported.   On 02-Oct-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, anatomical location: right deltoid, route of administration: not reported) for influenza prophylaxis. The batch number reported was P100244639 and expiry date: 23-Jun-2021.   On an unspecified date in Oct-2020, an unknown amount of time after receiving Afluria Quadrivalent, the patient experienced problems when lifting her right arm. The patient was seen by her healthcare professional (HCP) and was given steroids. The patient reported it felt better but was hurting again now.   At the time of initial reporting on 20-Oct-2020, the patient had not recovered from events.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  This case is linked to cases 202005333 and 202005338 (the same reporter).  Company comment: A female patient of unspecified age was administered Afluria Quadrivalent vaccine. An unknown amount of time after receiving Afluria Quadrivalent, the patient experienced pain in extremity and injected limb mobility decreased. The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine is assessed as possibly related.; Sender's Comments: A female patient of unspecified age was administered Afluria Quadrivalent vaccine. An unknown amount of time after receiving Afluria Quadrivalent, the patient experienced pain in extremity and injected limb mobility decreased. The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine is assessed as possibly related.
Sore shoulder after first dose; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Sore shoulder after first dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 089L20A and 025A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced ARTHRALGIA (Sore shoulder after first dose). At the time of the report, ARTHRALGIA (Sore shoulder after first dose) outcome was unknown. Not Provided          Relevant concomitant medications included amour thyroid and ketoconazole shampoo. Treatment information was not provided.  On 7 Mar 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 025A21A) intramuscularly for prophylaxis of COVID-19 infection.   This case was linked to US-MODERNATX, INC.-MOD-2021-057956 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-057956:2nd dose case
Pt was admitted to the hospital on 7/27 for gangrene of the toe of the right foot (with osteomyelitis). He was tested for COVID on 8/1 after having a fever and congestion the day prior.
Nose Bleed for 5 & 1/2 hours on 04/25/2021 Coughing Large chunks of Dark Blood 04/25/2021 Black Stool on 04/26/2021 - patient is better and improving Severe Fatigue Rash on Chest, Arms and Thighs, Upper Chest, Under Bilateral Breasts
My right arm at injection site is in severe pain and a lot of discomfort which mild swelling; My right arm at injection site is in severe pain and a lot of discomfort which mild swelling; My right arm at injection site is in severe pain and a lot of discomfort which mild swelling; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jun2022 at 15:00 as dose 1, single (Lot number: FJ4989) at the age of 36 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: INJECTION SITE PAIN (non-serious), INJECTION SITE DISCOMFORT (non-serious), INJECTION SITE SWELLING (non-serious) all with onset 08Jun2022 at 15:00, outcome "not recovered" and all described as "My right arm at injection site is in severe pain and a lot of discomfort which mild swelling". The events "my right arm at injection site is in severe pain and a lot of discomfort which mild swelling" required physician office visit. Therapeutic measures were not taken as a result of injection site pain, injection site discomfort, injection site swelling.  Additional Information: The patient was not tested for COVID-19 since vaccination. Prior to vaccination, the patient was not diagnosed for COVID-19. The patient didn't receive any other vaccination within 4 weeks of COVID-19 vaccine.
Information has been received from a physician concerning an infant patient, who on an unspecified date was accidentally vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported) which was not indicated for patients under two years of age when they were supposed to give PREVNAR 13. The physician said they got he numbers confused with the 23 and 13. Follow up information has been received from a physician concerning a 16 week old (gender unknown) patient, who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported). There were no adverse reactions. This is one of several reports received from the same source. Additional information has been requested.
pt recv vax 5JUN95 went home w/mom & slept 15 mins pt started to cry 5PM-would not eat or sleep; pt cried till 830PM; took pt to ER & mom cont APAP & apply ice packs to leg; pain lt thigh; fever; crying; lt leg swollen;
Red swollen and warm right arm. treated with clindamycin for cellulitis but possibility of reaction is still there.
Pt had varicella 12/13/1996 at hospital, pt seen in office (health center) and was dx with Varicella.
Felt "sick" within 3 days of receiving Anthrax vaccine while out of country. Symptoms continued, but patient attributed to multiple factors (dietary changes, increased activity, decreased sleep, altered schedule, etc.) He was finally evaluated post deployment and diagnosed with chronic fatigue. He was medically boarded from the AF with diagnosis of CFS and has been following up at the hospital. Symptoms: Fatigue, Malaise >60 days, weakness, dizziness, unsteady, rare headaches, tinnitus, paresthesias, joint aches, muscle twitching, poor concentration  6/20/08 Reviewed medical records of  FINAL DX: multiple sclerosis, chronic fatigue syndrome, exertional asthma, chronic rhinitis, secondary reactive anxiety disorder, IBS, peripheral neuropathy & diminished hearing Records reveal patient experienced loose stools, upsept stomach & fatigue s/p initial anthrax vaccination 1991. Developed additional symptoms weakness, extreme fatigue, felt faint, lightheadedness, off balance, anxiety, panic attacks, restless, sleep difficulties, palpitations, weight loss, asthma, Gilbert's disease over time & was eventually diagnosed w/MS in 1998. 1/21/2010 Patient diagnosed with MS.
Fever; Chills; Green discharge from nose; Pain in spine; Mid chest pain; Mid back pain; Lost sensation in left hand; Arm weakness; High heart rate when standing; Trouble swallowing; Day by day got more tired; Weak; Loss of feeling; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), RHINORRHOEA (Green discharge from nose), SPINAL PAIN (Pain in spine) and CHEST PAIN (Mid chest pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history provided).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills), RHINORRHOEA (Green discharge from nose), SPINAL PAIN (Pain in spine), CHEST PAIN (Mid chest pain), BACK PAIN (Mid back pain), SENSORY LOSS (Lost sensation in left hand), MUSCULAR WEAKNESS (Arm weakness), HEART RATE INCREASED (High heart rate when standing), DYSPHAGIA (Trouble swallowing), FATIGUE (Day by day got more tired), ASTHENIA (Weak) and FEELING ABNORMAL (Loss of feeling). At the time of the report, PYREXIA (Fever), CHILLS (Chills), RHINORRHOEA (Green discharge from nose), SPINAL PAIN (Pain in spine), CHEST PAIN (Mid chest pain), BACK PAIN (Mid back pain), SENSORY LOSS (Lost sensation in left hand), MUSCULAR WEAKNESS (Arm weakness), HEART RATE INCREASED (High heart rate when standing), DYSPHAGIA (Trouble swallowing), FATIGUE (Day by day got more tired), ASTHENIA (Weak) and FEELING ABNORMAL (Loss of feeling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported   No treatment medication reported   This case was linked to MOD-2021-041495 (Patient Link).