chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; Vaccine was administered to 8 patients after 1 day of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 prophylaxis.     Medical History or Condition were not reported.     On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to 8 patients after 1 day of expiry).    Reported patients were both male and female, none of the patients reported being pregnant or breastfeeding.  Concomitant product use was not provided by the reporter.  Expiry date of the vaccine was 04-Apr-2022. All of the vaccine administered were boosters. Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.  This case contains information about patient 7th out of 8 adult patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735621 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735621:Master case, Patient 1
I started getting severe hot flashes many times a day on day 6 after vaccine.  I am POST-menopausal, haven't had a hot flash in at least two years and never had very many when I did.  This is so severe and frequent, I had more in the first week than I'd had in my lifetime up to that point.  On day 16 now (day 22 since vaccine) and still happening all the time.  I may have my estrogen checked to see if any changes since last test.   Would like to know how long this might last.
Group B Streptococcus; Vaccine exposure during pregnancy; This observational study case was received on 25-Feb-2021 from other health professional and concerned a 25-year-old, pregnant female subject of body weight: 151 lbs, height: 65 inches and body mass index (BMI): 25.1, enrolled, a prospective observational safety study.   The subject's concurrent conditions included body mass index high (BMI: 25.1), body itch and drug allergies. The subject's concomitant medication included OB complete (multivitamin, multimineral) for healthy pregnancy.  The subject had no obstetrical history. The subject had no history of offspring with major congenital malformation (MCM). The subject had no maternal or paternal history with MCM.    The subject's last menstrual period (LMP) date was 01-Aug-2020, estimated delivery date (EDD) was reported as 08-May-2021 and corrected estimated date of delivery (CEDD) was not reported. The type of pregnancy was singleton. The subject did not use tobacco, alcohol or illicit drugs during pregnancy.   On 09-Sep-2020, at gestational age of 5 weeks (calculated per LMP), the subject was vaccinated with Afluria QIV (Flu Vaccine Egg Split QIV CSL) (influenza vaccine; dose, route of administration and anatomical location: not reported) (explicitly coded as 'Vaccine exposure during pregnancy') for influenza immunisation. The batch number reported was P100239705.  On 15-Oct-2020, cystic fibrosis mutation analysis revealed no MCM.  On 23-Oct-2020, first trimester screen revealed no MCM.  On 14-Dec-2020, second sequential screen revealed no MCM.  On an unspecified date, an unknown amount of time after receiving Afluria QIV, the subject developed group B Streptococcus infection.  On 21-Jan-2021, the subject was treated with clindamycin, at a dose of 300 mg, three times a day, orally, until 27-Jan-2021.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The event of 'bacterial infection due to streptococcus, group B' was considered to be medically significant by a Physician within Seqirus's Pharmacovigilance and Risk Management Department.  Company comment: A 25-year-old subject was administered Afluria QIV at gestational age of 5 weeks. On an unspecified date, an unknown amount of time after receiving Afluria QIV, the subject developed group B Streptococcus infection. Causal role of the suspect vaccine is assessed as not related, due to biological implausibility. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.; Sender's Comments: A 25-year-old subject was administered Afluria QIV at gestational age of 5 weeks. On an unspecified date, an unknown amount of time after receiving Afluria QIV, the subject developed group B Streptococcus infection. Causal role of the suspect vaccine is assessed as not related, due to biological implausibility. Vaccine exposure during pregnancy is assessed as unrelated per company's conventions.
This spontaneous report was received from a pharmacist refers to a patient of unkonwn age and gender. On 05-MAR-2014 the patient was vaccinated with an expired PNEUMOVAX 23 (Lot# was reported as H018944, expiration date 01-MAR-2014), 0.5 ml, intramuscular (indication unspecified), which was expired on 01-MAR-2014. No symptoms reported. Additional information has been requested.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (arm sore at the injection site) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 048A21A and 041B21A) for COVID-19 vaccination. No medical history reported. On Mar 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 20, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 23, 2021, patient had vaccination site pain/arm sore at the injection site (medically significant). At the time of the report, vaccination site pain (arm sore at the injection site) outcome: unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information. This case linked to MOD-2021-333763 (patient link). Sender's comments: This case concerns a 26 year-old male patient with no reported medical history, who experienced the expected non-serious event of vaccination site pain. The event occurred on the same day as the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The seriousness of criteria of medically significant was overridden based on medical judgement and review of source document that does not include information supporting seriousness criteria.
Pt. recv. vax. on 04/22/98.  On 4/24/98, pt. slept between his two grandparents in the same bed.  On 4/25/98, grandparents awoke and noted that the infant was no longer breathing.  EMS called.  Pt. taken to hospital.
Subsequent to receiving varicella virus vaccine live, the pt experienced a fever and varicella like rash at the injection site. The pt had an unknown number of lesions. Additional information has been requested.
Death; received the Vaccination and paralyzed her. Not long after she died; This case was reported by a consumer via media and described the occurrence of unknown cause of death in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and paralysis (serious criteria disability and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the paralysis was unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine. The reporter considered the paralysis to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported for the reporter's friend and ex-coworker. The age at vaccination was not reported. The patient received Shingles vaccine and it paralyzed her.  Not long after that, the patient died.  The reporter suggested to research and have conversations with the doctor.  Reporter stated that, everyone reacted differently from every medication.; Reported Cause(s) of Death: Unknown cause of death
This spontaneous report as received from a health professional refers to a 4-year-old male patient with 1 sibling and no preexisting allergies, birth defects and medical conditions. On 29-OCT-2015, the patient was vaccinated with the first dose PROQUAD (Merck) lot # K020750, expiration date 30-APR-2016 (dose and route of administration not reported). It was reported that the patient received improperly stored vaccine. There were temporary excursions recorded due to the personnel not setting / clearing the minimum and maximum temperature correctly. No adverse events or symptoms occurred. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
On The April 21 I had one quarter size mark that was itchy.  Thought I got bit by a spider.  It didn't go away. A week later I had three quarter size red marks on left hip in a triangle pattern.  Needed to get second shot and figured these were not related to the vaccine.  After receiving second shot in the arm it bleed.  Person held pressure on it and told me it would bruise .  This was on May 2nd at 8:10 am.  It was lot number EW0167.  Clinic site.  Received medical care at express care for spreading rash and itching on Tuesday May 4th.   20mg twice daily.  Was placed on predizone 40mg, Zrytec 20mg twice daily, Benadryl 50mg every 6 hours, famotidine May 8th still spreading on thigh toward knee.  Chicken pox like marks on stomache and back.  Going to medical center today May 8th.
This case was reported by a consumer and described the occurrence of erythema in an 8-week-old male subject who was vaccinated with Engerix B (GlaxoSmithKline) for prophylaxis.  A physician or other health care professional has not verified this report.  The reporting consumer is the patient's mother.  Concurrent vaccination included Infanrix (GlaxoSmithKline) given on 31 May 2007.  There were no concurrent medications.  On 31 May 2007 at 11:00 the subject received the 1st dose of Engerix B (0.5 ml, in the "upper leg").  On 31 May 2007, less than one day after vaccination with Engerix B, the subject experienced redness (not otherwise specified).  The reporter also believed that the subject "was vaccinated with a half dose of Engerix B vaccine" (possible medication error); however, it was noted that the lot number provided corresponded with the pediatric formulation for Engerix B.  On 1 June 2007, the redness was resolved.
Within 5 minutes after HPV administration, patient was sitting up on bed, put her head in her lap then jerked backward suddenly. Hit head on wall and was stiff all over body for about 5 seconds. Immediately awake, alert. No other problems.
Cellulitis in left arm at injection site. Swelling and pain of left axilla lymph nodes
This spontaneous report was received from a 60-year-old female patient and refers to herself. The patient's concurrent conditions included ductal carcinoma in situ (DCIS). It was reported that the patient did not have any drug reactions or allergies, however the patient's concomitant medications included unspecified allergy medicine. Other concomitant medications included MAGNESIA and unspecified fiber tablet. On an unknown date, after receiving the ZOSTAVAX, the patient experienced a shingles outbreak, which was very painful. The patient sought a medical attention by contacting the physician. The unspecified treatment was given for the event. No laboratory diagnostics studies were performed. The outcome of the event was reported as not recovered at the time of this report. The relatedness between the event and the ZOSTAVAX was not reported. Additional information has been requested.
Patient received vaccine at 0815. At 12:00 Patient arrived in clinic with hives on face neck and chest area. Facial flushing noted. BENADRYL PO given.
24 Hrs after vaccines were given presented with rash maculo papular on chest, back and abdomen at the same time fever initially 100.4, went to to 103 x 3 days; on 3rd admitted to hosp continued with fever up to 102.5, 2 more days rash fade off fast with Hydroxyzine PO.  06/12/2007 MR received for a 4 day hospital admit (1/2-6/07) for c/o maculopapular rash on infant's abdomen, chest, and back as well as fever.  Infant has been crying more, greatest when fever is high.  Admitted for febrile illness. D/C DX: Viral Infection non-specified.  Thrombocytosis resolved.
Severe generalized body rash 10 days following vaccination. Mother reports patient "felt warm" for a couple days before breakout on 04/27/14. Rash red and raised, causing some itching, small ulcer on buccal mucosa. Patient afebrile. Treated at home with Aveeno oatmeal baths and Benadryl P.O. Patient examined in our office on 04/29 and again on 05/01/14. Rash improving significantly. Mother advised to keep patient away from children for 4 days after disappearace of rash and until labs return. Report any mental status changes or body aches and pains to our office.
Pt received vaccination on 9/29/13 at 12:30 pm, developed red inflamed area around injection site on 10/1/13 which worsened throughout day. Pt saw doctor evening of 10/1/13 and reports she was prescribed BACTRIM (filled elsewhere). Affected area was about 3 inches in diameter.
Extremely sore injection site, becoming difficult to lift, extend, or rotate arm (despite having moved arm quite a lot immediately after vaccination so as to prevent this).  Growing headache throughout the day, becoming an ice-pick headache through the night that has continued into this - the next day.  Alternating feeling of being overheated and having chills overnight, though no actual fever.  Generally feel like I have the flu. I did not react this way to either of the original two doses - only to this booster shot.
Weakness, tremors, loss of appetite.  My mother never really recovered after this. She was hospitalized a week or so after receiving the vaccine. She contracted a "community aquired pneumonia" in the hospital then had to go to a rehab center.  his was the beginning of the end for her. She was weak with tremors and loss of appetite and nausea for weeks.
Red bump; Red bump; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE INFLAMMATION (non-serious), ERYTHEMA (non-serious), outcome "unknown" and all described as "Red bump".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Tinnitus significantly louder, acute sensitivity to noise, ears popping and increased noise sensitivity when barometer drops before rain
Pt received vaccine for 12+ age, lot number did not match. Pt had no reactions. Checked with CDC website rec's, pt to not receive additional dose. Mother of child updated. No adverse reaction noted.
He had a fever & diarrhea lasted about 2 day. Contacted the doctor on 2nd day & was told to keep him hydrated & give Tylenol every 4 hours. Altered between the Motrin & Tylenol to break fever.  After about a day or so he was feeling better.
After getting the vaccine I experienced a breathing problem, it felt like my neck was being squeezed.. A month after the vaccine it felt like it was getting worse. I went to the doctor and was told that my lymph nose was swollen.
Skin rash/hives first appearing on chest and back ~10 hrs following injection (3/11/21). Each day progressing in severity and spreading to upper arms, neck, head, waist.  Went to dermatologist on 3/15/21 and received antihistamines and other topical creams. Skin rash remains severe.
Patient presented with redness on the arm that she received her vaccine in. The site of injection was swollen, and she had a fever. Patient was instructed to take diphenhydramine and ibuprofen to help with the redness, swelling, and fever.
Patient with warm feeling and swollen tongue day of vaccine, resolved tongue symptoms, now with residual left cheek swelling.
Patient felt well sitting in vaccination room for a couple minutes.  While walking to chair a few steps aware she suffered dizziness and loss of balance that led to a fall.  She never lost consciousness and felt better almost immediately.
ringing sound in both of his ears; constant dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 63-year-old male patient received BNT162b2 (BNT162B2), in 2020 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Balance therapy" (unspecified if ongoing), notes: balance therapy. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First primary series dose in Oct2020), administration date: Oct2020, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 2020, outcome "not recovered", described as "constant dizziness"; TINNITUS (non-serious) with onset 2020, outcome "not recovered", described as "ringing sound in both of his ears". The events "ringing sound in both of his ears" and "constant dizziness" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tinnitus, dizziness.  Additional information: The report was not related to a study or programme. Reporter mentioned that she was calling on behalf of her friend who had been suffering from symptoms for a year and a half. Her friend had consulted a Neurologist, an ENT for some symptoms and reactions to original covid vaccine which her friend received. Reporter stated "He had constant dizziness, when he moves along with ringing in the ear, those are getting worse. He had all kind of ear tests, he had an MRI on his brain, he had blood work, and balance therapy, He had taken Meclizine, and nothing had helped, actually the Meclizine made it worse. It made him feel worse because he was very drowsy. The patient mentioned that the patient received the first primary series dose in Oct2020 and two weeks after he received the second Primary dose, Symptoms started to appear.  Patient received first dose Pfizer BioNTech Covid-19 vaccine Monovalent Oct2020. 2 weeks after patient received second dose Covid-19 vaccine, the symptoms started to appear. Clarified that reporter had only mentioned the date of the first dose of the vaccine and experienced symptoms after second dose of Covid-19 vaccine. . No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I woke up 15APR2023 with what I though t were allergies symptoms from mowing the grass the previous day.  I went through the weekend and on 17APR2023 I took two COVID-19 test both were positive. I called and made a telehealth appoint for 18APR2023 and was prescribed Paxlovid and suspended my Eliquis due to possible reaction.
Redness down left arm from shot area to above elbow.  Counseled patient to take otc benadryl and keep an eye on area. If worsens, to see medical care from physician.
This spontaneous report has been received from a registered nurse, concerning an 11 year old male patient. It was reported that the patient had no drug reactions, allergies or pertinent medical history as well as concurrent conditions. Concomitant medications included prednisone, iron, MIRALAX, famotidine and amitriptyline. On 27-SEP-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot number M009116 (strength, frequency, route of administration and expiration were not provided) for prophylaxis (reported as recommended for age group). Later, in November 2016 (reported as 2 months later), the patient developed a dry spasmodic cough. On 28-NOV-2016, the patient received the second dose of GARDASIL 9 (strength, frequency, route of administration, lot number and expiration were not provided) for prophylaxis (reported as recommended for age group) and on an unknown date, the patient developed generalized muscle weakness, pain and inability to walk that required the use of a wheelchair. On 10-MAY-2017, the patient was admitted a Hospital and on an unknown date, the patient was diagnosed with dysfunctional neurologic disorder. On an unknown date approximately in 2017, the patient had a computerized tomography (CT) scan of his chest that showed a left lower lobe consolidation that started on an unknown date. In addition, other laboratory studies were performed: complete blood count (CBC), complete metabolic panel, urinalysis, mercury level, vitamin D, lipid panel, aluminum and selenium level with unspecified results. The patient was treated with unspecified antibiotics. On 03-JUN-2017, the patient was discharged from the hospital. On an unknown date approximately in 2017, the reporter stated that the patient suffered from depression. At the time of reporting, outcome for dry spasmodic cough, dysfunctional neurologic disorder, left lower lobe consolidation and depression was unknown. The causal relationship between these adverse events and the therapy with GARDASIL 9 was not assessed. The event dysfunctional neurologic disorder was considered as a disabling event.
One hour after receiving vaccine, I had lost my memory until the next afternoon. I woke up in the hospital and was diagnosed With TGA (Transient global amnesia). Took a few days to get back to normal.
A nurse reported that a 3 year old female received an injection of Prevnar on 10/23/01. The pt had a runny nose at the time of vaccination. On the same day, post vax, the pt experienced a fever, runny nose, was not eating and was noted to have cried "all night". She also developed redness on her arm. It was noted that the pt experienced these same symptoms after receiving a dose of Prevnar on 8/23/01, see HQ8068606NOV2001. The pt recovered after being treated with Benadryl. The events were considered to be "Medically Important" by the reporter. Follow up information received on 12/13/01 from the original reporter that clarified the patient's birth weight and number of siblings. The events required a visit to the doctor's office.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 1/21/2021 and 2/24/2021. Patient was admitted for hypoxic respiratory failure due to COVID-19, which was complicated by GI Bleed and ultimately superimposed bacterial pneumonia. Patient was transitioned to comfort care on 11/1/2021 and expired on 11/2/2021.
Pt recvd DTP 4JUN91 & parents returned to clinic w/pt today; pt has bruised area 8-9cm, lump under bruised area size of half dollar; On 9JUN area started draining thick yellowish discharge; Pt taken back to MD;
Day 1- swollen lymph nodes in groin and right axillary area, pain/swelling in most joints of the body, including hands, feet, ankles, knees, neck, spine Day 2- shingles in right groin area; continued swollen lymph nodes and joint pain