chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Have recurring like shingles/Suspected vaccination failure; Have recurring like shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 02-Mar-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient was lucky that received two different shots and still had recurring like shingles. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow up would not possible, as no contact, details were available. As it was not clear if patient had different shots was of same manufacturer or different, hence conservatively coded both as suspect.
pneumonia, illness; missed her 2nd appointment; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia, illness) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia, illness) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (missed her 2nd appointment). At the time of the report, PNEUMONIA (pneumonia, illness) and PRODUCT DOSE OMISSION ISSUE (missed her 2nd appointment) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant meds: H. blood pressure medicines.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Extreme vertigo, nausea, vomiting, chills, headache, stomach ache, body aches.
My period which was once entirely regular to the day, is now very irregular. I track my cycles on an app and the first and second periods after the shot were very long with spotting and then my November period was mostly nonexistent (just some light spotting). This is extremely unusual me and, in fact, has never happened before the second vaccine.
I started 2 days after receiving the 2nd dose with nausea. I saw my gastro twice and had a endoscopy on May 12, 2021 which the results were mild inflammation and acid reflux. I was put on Dexilent twice a day with minor relief. I again went to see my Gastro Dr. and no firm diagnosis was made. After having nausea and stomach pain since March, which got progressively worse, I changed Dr. with the hope he may be able to make a firm diagnosis. He suggested I repeat the endoscopy as the first one showed more that a "mild inflammation" which I proceeded to have on September 30, 2021. After the results he suggested that I see a Hematologist/Oncologist as he suspects it is a blood disorder. On October 7, 2021 I had numerous vials of blood taken and the end result is  Auto Immune Gastritis, a complicated inflammation of the stomach. I also am told my blood test revealed that I have antibodies for Pernicious Anemia .I follow up with an endoscopy every year and never was diagnosed with Auto Immune Gastritis or that my stomach issue was related to a possible blood disorder. My belief is that it was caused by my Moderna Vaccination and is definitely an after effect of it, which I have to follow up on for the rest of my life.
Dizziness; Headache; Bleeding 6 days later; Another period; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route of administration in the left arm on 26Mar2021 at 15:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, chronic allergies, asthma, premenstrual syndrome (PMS) and ovulation pain. The patient had no known allergies. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride (ZYRTEC), DIM supplement and prenatal vitamins from unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 10:00, the patient experienced dizziness and headache, was not sure if the events were the result of the vaccine until the patient was supposed to ovulate the 11 days later (the patient felt ovulation and always cramp with ovulation), the patient started with another period and was still bleeding 6 days later while the patient has had 4 day cycles the entirety of 24 years of menstruating. 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. The clinical outcome of the events dizziness, headache, cramp with ovulation, bleeding 6 days later and another period was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
9 year old male patient, vaccine administration PFIZER first dose at 3:40pm, after 5 minutes of being in the observation area, he had 2 strong episodes of emesis, his mother indicates he had a small breakfast, staff laid the patient down on the floor. He was given water and a snack. Later he was feeling better.
her nose feeling stuffed and clogged; trouble breathing; heart palpitates; headache; fatigue; body aches; bumps on her face and body; bones hurt; throat hurts; her eye is red and itching; her eye is red and itching; She experienced an allergic reaction throughout her body; This is a spontaneous report from a contactable consumer via medical information team. A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 25Aug2021 as dose 1, single for COVID-19 immunization. Medical history included she went through COVID very bad last year from 2020 to an unknown date. The patient's concomitant medications were not reported. On an unspecified date in 2021 the patient experienced her nose felt stuffed and clogged, trouble breathing, heart palpitates, this has been going on for 3 weeks, headache, fatigue, body aches, bumps on her face and body, bones hurt, throat hurts, her eye is red and itching, she experienced an allergic reaction throughout her body. Outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 04-MAY-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Nausea & stomach pain; Nausea & stomach pain; This is a spontaneous report from a contactable other health professional.  A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK9231, via an unspecified route of administration, in the left arm from 08Jan2021 10:00 to 08Jan2021 10:00 at a SINGLE DOSE for covid-19 immunization; propanolol hcl, via an unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication. Medical history included long QT syndrome and latex allergy. Concomitant medications included mexiletine, bupropion and duloxetine hydrochloride (CYMBALTA).  The patient experienced nausea & stomach pain on 09Jan2021 09:00. The outcome of events was recovering. No treatment was received/required due to the events.  Information on Lot/Batch has been requested.
99 degree temperature; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (99 degree temperature) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (99 degree temperature). At the time of the report, PYREXIA (99 degree temperature) outcome was unknown. Not Provided          Relevant concomitant product usage were not reported by the reporter. No treatment details were added. Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to US-MODERNATX, INC.-MOD-2021-114367 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114367:Case for mother
08/28/22 presents to ED for "fatigue". PMHx of "CAD s/p remote stenting, HTN, HLD, BPH, right inguinal hernia s/p repair 8/15"
PATIENT AWAKENED TO SHORTNESS  OF BREATH AND A RASH/HIVES ALL OVER CHEST AND ARMS. SELF TREATED WITH A DOSE OF BENADRYL. SHORTNESS OF BREATH WENT AWAY BUT HIVES REMAINED
Raised rash on left arm. Rubbed Benitryl  morning and night. Seems to be fading at this time. Very sore and sometimes itchy
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2015, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
101.3 degree fever, chills, sweating, nausea, vomiting, diarrhea, swollen lymph nodes, axillary lymph node pain, migraine, photophobia, lack of appetite, fatigue, malaise
Apparent life threatening event: On the day in question patient turned "yellow" then pale. He became lethargic and became cool. He stopped crying and appeared as though he couldn't breathe. Mother reports to have adminstered 10 rescue breathes over the next few minutes whereupon the baby began to cry, but was noted to be "loose." Mother denies any excessive regurgitation, vomiting, feeding difficulties, or back arching. 12/14/09 DC summary received for DOS 11/15/09-11/19-09. Mom reported to ED staff that evening before admission pt. appeared yellow then turned pale, lethargic, cool and flaccid. Appeared not to breathe.  Mom administered rescue breaths and pt. began to cry. 4 vaccines given on day of admission by history.  Pt. was admitted to PICU for observation. Neuro consult , LP done, Cardiology consult obtained for long Q-T on EKG .  Pt. discharged stable to f/u with PCP and Cardiologist. DC DX: Apparent life threatening event, Long Q-T, non syndromic 12/17/09 ED and Hospital records received for DOS 11/15/09-11/19/09.
A little tired after the first two Pfizer COVID vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received bnt162b2 (BNT162B2), administration date 28Mar2021 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single and administration date 19Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "A little tired after the first two Pfizer COVID vaccines".  Additional information: The events did not require emergency room or physician's office. The patient did not have other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  Follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient was receiving her Pfizer COVID19 vaccine. Pre-medicated with bendadryl 25mg PO given mild allergic reaction to first dose. Pt  began having throat swelling, wheezing, and coughing 30 minutes after receiving vaccine. Took another Benadryl 50 mg and Prednisone 20 mg with no relief.  Taken to ER where rash began as well. Given epinephrine 0.3mg IM, racemic epinephrine inhalation, famotidine 20mg PO, methylprednisolone 125mg IM. History of multiple allergies. Discharged from ED with follow-up with primary care.
Redness and itching. Spread for four days to 6inch by inches. Still itching.
Disrupts sleep; disrupts concentration on daily activities; fatigue; fever (102); ringing in ear getting worse(louder)/ increased; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in ear getting worse(louder)/ increased), INSOMNIA (Disrupts sleep), DISTURBANCE IN ATTENTION (disrupts concentration on daily activities), FATIGUE (fatigue) and PYREXIA (fever (102)) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Allergic to sulfa antibiotics.), Allergic reaction to analgesics (Allergic to drug Codeine.), Hypertension since 2009, Hyperlipidemia since 2009, Hypothyroidism since 2009 and Tinnitus (Mild tinnitus) since 1978. Concomitant products included ROSUVASTATINE [ROSUVASTATIN] from 2009 to an unknown date for Hyperlipidemia, HYDROCHLOROTHIAZIDE from 2009 to an unknown date, BENAZEPRIL from 2009 to an unknown date and AMLODIPINE from 2009 to an unknown date for Hypertension, LEVOTHYROXINE from 2009 to an unknown date for Hypothyroidism.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced TINNITUS (ringing in ear getting worse(louder)/ increased). On 28-Aug-2021, the patient experienced FATIGUE (fatigue) and PYREXIA (fever (102)). On an unknown date, the patient experienced INSOMNIA (Disrupts sleep) and DISTURBANCE IN ATTENTION (disrupts concentration on daily activities). On 29-Aug-2021, FATIGUE (fatigue) and PYREXIA (fever (102)) had resolved. At the time of the report, TINNITUS (ringing in ear getting worse(louder)/ increased) had not resolved and INSOMNIA (Disrupts sleep) and DISTURBANCE IN ATTENTION (disrupts concentration on daily activities) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2021, Body temperature: 102 (High) Fever 102 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient had mild tinnitus from the past years but the intensity was increased just a few hours after the first dose of vaccination  Treatment information was not reported   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Non-Significant FU, updated reporter information. On 07-Oct-2021: Significant follow up received included patient demographics, relevant Medical history, lab investigation Concomitant medications; Outcome of the event tinnitus updated from unknown to not recovered; Events Fatigue, pyrexia, Disrupts sleep, disrupts concentration on daily activities;
Pt here receiving first dose of Pfizer covid vaccine. Pt requested that someone sit with her due to her being extremely nervous and having previous anaphylactic reactions in the past. The patient and I began to talk about our children, jobs and hobbies when she started to complain that her throat was really dry and raspy. The patient was given water and her vitals were taken. Pt is tachycardic. Vitals are160/100. , HR is 125 RR are 22 02 is 100. Pt is alert and oriented and states she is ok and would like me to update her husband and sister. Pt offered further medical attention and accepted. 911 called at 12:32 by Rn site lead. Benadryl administered to left deltoid at 12:29 By Rn . 911 operator advised RN to administer epi. Epi administered by RN at 12:32. Pt is alert oriented x3 . Ambulance arrived at 12:45 to transport pt to local hospital for further evaluation, Husband and sister notified. Pt Left this facility at 12:55.   Pt Vaccinated on 3/24/2021 11:55 Right deltoid Pfizer 1st dose  Adverse event began at 12:10    transferred care 12:45
SWELLING IN EAR; RINGING IN HER EARS; HARD TO HEAR OUT OF HER EARS; This spontaneous case (PVX2019-1533) report was received from a consumer on 13-Jun-2019. It described a 43-year-old female consumer who experienced the events "ringing in ears", "hard to hear out of ears", and "swelling in ear", after the administration of oral Vaxchora, for cholera and injectable Varicella vaccine (non-company suspect) for chicken pox.  Case report: The consumer took Vaxchora on 10-Jun-2019 and Varicella vaccine on 12-Jun-2019. After that, she experienced ringing in her ears, she was unable to hear out of her ears. She reported that the ringing sound was like "the sound in ear being weird, as if you pop your ear on a plane" but without the pressure experienced while on a plane. She also stated that when she spoke, it would echo, and stated it was similar to "when sinuses affect ears". On 13-Jun-2019, the events had worsened. Additionally, she reported that "getting a funny sensation in the ear, not so much vibrations, but troubled hearing like when your ears clog on the plane". She was prescribed prednisone (6 mg; to be tapered off) to reduce the swelling in the ears and to prevent hearing loss.  The consumer's medical history included ear infection, hypothyroidism, atrial fibrillation, pernicious anemia, and vitiligo .  Concomitant medications included levothyroxine (175 mcg; once in a day) for hypothyroidism, Multaq (dronedarone; 400 mg; twice a day) and metoprolol (25 mg; once in a day) for atrial fibrillation. The past medication included intravenous (IV) iron infusion (about a week ago).  Action taken with Vaxchora and Varicella was unknown.   The consumer had not recovered from the events.  The reporter considered the events unrelated to Vaxchora because until she received the Varicella vaccine, she had no reaction.  Company's Comment: In this case, it was reported that a 43-year-old female consumer experienced the events "ringing in ears", "hard to hear out of ears", and "swelling in ear", after the administration of oral Vaxchora for cholera and injectable Varicella vaccine. Although the events were reported with reasonable time relationship to intake of the Vaxchora vaccine; however, there is also intake of varicella vaccine which is more likely to contribute to these events. Hence, the causality of the events  with Vaxchora is considered as unlikely.; Sender's Comments: Company's Comment: In this case, it was reported that a 43-year-old female consumer experienced the events "ringing in ears", "hard to hear out of ears", and "swelling in ear", after the administration of oral Vaxchora for cholera and injectable Varicella vaccine. Although the events were reported with reasonable time relationship to intake of the Vaxchora vaccine; however, there is also intake of varicella vaccine which is more likely to contribute to these events. Hence, the causality of the events  with Vaxchora is considered as unlikely.
Pt recvd vax & exp premature ventricular contractions & chest pain; 4 days later was found to have a mitral valve heart murmur; condition of pt is currently being labeled as GBS synd;
Pneumonia; Pneumonia; I was tired; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program, PCV20 Adult Consumer Quant DTC Testing.   A female patient of an unspecified age (reported as 70 unit of measure not provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13; lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, single dose for immunization.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had pneumonia once and was sick for months and was tired for a long time afterwards. Fortunately, the patient didn't have to go to the hospital, but felt badly enough to go. When her primary physician thought things were headed in that direction, the patient was treated with the strongest medications possible, and checked with her at home, with regularity. The patient had taken the (Prevnar) vaccine prior to this event. Outcome of the events was unknown.  Information on Lot/Batch number has been requested.