chrisvoncsefalvay/vaers-outcomes huggingface dataset:
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  This case contains information for patient 82 out of 100 patients reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Menstrual cycle started early - next day (08Mar2022) after the vaccine received and lasted for 14 days.   My normal menstrual cycles occur every 28 days and last 5-7 days.   Previous menstrual cycles after the vaccinations are as follows: I had the first dose of Pfizer vaccine on 14Jun2021 and my menstrual cycle started early on 22Jun2021 and stopped on 28Jun2021. After the second vaccine on 06Jul2021, my menstrual cycle started on 15July2021 and lasted for 8 days.   Soreness at injection site for 6 days. The soreness started 07Mar2022 and stopped 12Mar2022.   Chills (no fevers) for 2 days 07Mar2022-08Mar2022.   Achy body and muscles for 5 days 08Mar2022-12Mar2022.
8 days post-injection: scalp and hand severe pruritis. 9 days: erythema in hands, neck and continued pruritis, 12 days: erythema on face, groin, hips and hands, significant swelling of hands with edema, angioedema of the face and neck. 14 days: angioedema much worse with increased facial and neck edema, severe pruritis of hands and arms, urticaria on arms and sides with fine nodular rash.  With use of low dose methylprednisolone, oral antihistamines, topical steroid creams, gradual improvement.
Typical signs of infection, individual tested positive for Covid with a rapid test.; Typical signs of infection, individual tested positive for Covid with a rapid test; Breakthrough infection 4 months after second dose.; This is a spontaneous report from a contactable consumer. A 51-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date in Apr2021 (at the age of 51-years-old) as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if other vaccine in four weeks. No covid prior vaccination. Covid tested post vaccination was yes. On an unspecified date in Aug2021, breakthrough infection 4 months after second dose. Typical signs of infection, individual tested positive for Covid with a rapid test. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with REGEN-COV. The patient underwent lab tests and procedures which included sars-cov-2 test positive (nasal swab): positive on an unspecified date in Aug2021. The outcome of events was recovering.  Information on the lot/batch number has been requested.
Full body rash, itching (small red bumps). Headache all day (6 on scale of 10) still gets them. Started 1 week after vaccination. Note: vaccine given 9/17/13 at pharmacy.
He had the 1st 2 shots and caught a "mild case" of COVID19 afterwards; He had the 1st 2 shots and caught a "mild case" of COVID19 afterwards; This is a spontaneous report from a Pfizer sponsored Program. A contactable male consumer reported for himself that he had received the first dose of BNT162B2 (Lot number unknown) and the second dose of BNT162B2 (Lot number unknown), both at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drugs were unknown.  The patient stated he had the 1st 2 shots and caught a "mild case" of COVID19 afterwards.  Outcome of the event was unknown.  Relevant test included SARS-CoV-2 test on unkwown date with positive result.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a physician for the Pregnancy Registry for GARDASIL, concerning a 15 year old female with bicornuate uterus and a history of chickenpox as child, on 17-SEP-2008 was vaccinated with a dose of GARDASIL (lot number, injection site and route not reported). Subsequently the patient was found to be pregnant. The date of last menstrual period was 01-SEP-2008 and the estimated delivery date is 08-JUN-2009. On 18-OCT-2008, the ultrasound showed that the patient had a bicornuate uterus. Follow-up information was received from the physician concerning the female patient. It was reported that during the pregnancy the patient also take NATELLE as prenatal vitamins. On an unspecified date the patient developed bacterial vaginosis, and on 18-NOV-2007 the patient was treated with FLAGYL 500 mg twice a day for 7 days. On 10-MAY-2008, at 36.5 weeks from LMP, the patient delivered a male baby, weighted 5 pound 6 OZ, APGAR score 7/7. It was reported that the baby was normal with no congenital anomalies. The physician also reported that during the delivery the patient had increased bleeding which was believed to be attributed to a partial placental abruption. Additional information is not expected.
Approx 8 days after 1st shot I was on lake late afternoon.  Temp started dropping at dark and both hands started getting extremely cold.  Temp was only about 58 degrees.  Back of hands started itching extremely bad, then seemed to be buring, and shortly after started freezing!  Couple of days later:  skin broke out in a rash with pea size blood blisters.   My first though was I had used some clorox and thought that might be the problem until I saw online about other blood blister reactions.  For 3 or 4 weeks when the temp got low (even down to 65) when I was outside my hands would get extremely cold.  I thought maybe because of a lack of blood circulation.  Skin on both hand over knuckles continued to peel and blister continued for approx 18 days.   As of today:  all blister are gone and skin has completely healed.   Although temps aren't as low now as back in Feb. I was out in 50 degree weather the other night and my hand don't seem to get freezing cold like before.  I think they are back to normal as well.  I did have my second shot on March 19.
Tiredness; Feeling unwell; Body ache; Light-headed; I had decrease of appetite; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 27Nov2022, stop date: 05Dec2022, notes: I had COVID-19 back in 27Nov2022 and I was diagnosed clear on 05Dec2022. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "COVID-19"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "COVID-19"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "COVID-19"; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization, reaction(s): "COVID-19". The following information was reported: PAIN (non-serious) with onset 09Dec2022, outcome "recovered" (10Dec2022), described as "Body ache"; DIARRHOEA (non-serious) with onset 09Dec2022, outcome "recovered" (10Dec2022), described as "Diarrhea"; MALAISE (non-serious) with onset 09Dec2022, outcome "recovered" (10Dec2022), described as "Feeling unwell"; DECREASED APPETITE (non-serious) with onset 09Dec2022, outcome "recovered" (10Dec2022), described as "I had decrease of appetite"; DIZZINESS (non-serious) with onset 09Dec2022, outcome "recovered" (10Dec2022), described as "Light-headed"; FATIGUE (non-serious) with onset 09Dec2022, outcome "recovered" (10Dec2022), described as "Tiredness". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Consumer stated, "I am calling regarding the vaccination of Pfizer, I had it on Friday and apparently I had told the nurse that I just came off COVID. I had COVID-19 back in 27Nov2022 and I was diagnosed clear on 05Dec2022, and she said you could take the vaccine (Pfizer COVID-19 vaccine), So I did it (event captured conservatively), but I have some side-effects. My side-effects were tiredness, feeling unwell, body ache, lightheaded, I had decrease of appetite and diarrhea from Friday to Saturday and I never had any side-effects from any other vaccines of Pfizer (further clarification unknown). This is number 5, the vaccine number 5 that I got, and I have a question. Can you still get vaccinated even though you have just gone through COVID-19, 5 days later?". Further probing could not be done as the consumer hung up the call abruptly. Hence limited information was available over the call.  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-202201369444 same patient/drug, different AE/dose;
Patient was administered vaccine that was improperly stored (in freezer for too long and considered expired by manufacturer at date of administration due to lack of study data). Patient was contacted and acknowledged recommendation but not interested in revaccinating at this time.
Narrative:  Patient received first covid vaccination within 25 days of having covid infection. Patient experienced "covid-like" symptoms. When presenting for second vaccine, provider decided to push second vaccination to three months.
Administered inactivated vaccine (Influenza) L arm and Shingles vaccine R arm.  Rash noted after administration of Inactivated vaccine.  Rash noted to Rt arm & then Lt arm.  Benadryl 50mg IM given.  Pt axox3.  Blood Pres 160/80, Temp 98.2, Pulse 72, Res 18, Pulse Ox 98%.
Patient had syncopal episode with seizure-like activity within 15 minutes of vaccination.  Fell out of chair and scraped nose and side of head.  Patient was transported to the ER by EMS.
This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (It started on my arm first. Swollen, red and itchy/And recently, my fingers and feet toes are swollen and red), ERYTHEMA (It started on my arm first. Swollen, red and itchy/And recently, my fingers and feet toes are swollen and red.), PRURITUS (It started on my arm first. Swollen, red and itchy), INSOMNIA (No sleep at night) and RASH (Rashes are all over my body, on and off) 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. No Medical History information was reported. On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (It started on my arm first. Swollen, red and itchy/And recently, my fingers and feet toes are swollen and red), ERYTHEMA (It started on my arm first. Swollen, red and itchy/And recently, my fingers and feet toes are swollen and red), PRURITUS (It started on my arm first. Swollen, red and itchy), INSOMNIA (No sleep at night), RASH (Rashes are all over my body, on and off) and HYPERSENSITIVITY (allergy symptoms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at a dose of Three times a day and CETIRIZINE HYDROCHLORIDE (CETRIZINE) for Itching, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (It started on my arm first. Swollen, red and itchy/And recently, my fingers and feet toes are swollen and red), ERYTHEMA (It started on my arm first. Swollen, red and itchy/And recently, my fingers and feet toes are swollen and red), INSOMNIA (No sleep at night), RASH (Rashes are all over my body, on and off) and HYPERSENSITIVITY (allergy symptoms) outcome was unknown and PRURITUS (It started on my arm first. Swollen, red and itchy) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. After the [patient took booster shot, the patient had allergy symptoms. It started on my arm first swollen, red and itchy. After 2 weeks rashes are all over body on and off first and recently finger and feet toes are swollen and red. The patient never seen this continuing rash on body on and off in life and since the first Moderna vaccine the patient had itchy and red arm on the injected site after 7 days for first shot. The patient took Benadryl three times a day when the itchiness made no sleep at night and tried cetirizine, still itchy. Benadryl works better but it makes drowsy and need to take it 3 times a day to ease the itchy feeling. This case was linked to MOD-2022-449535 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-Jan-2022: Follow Up received and added events, Suspect drug start date, and treatment medications.
Behavior changes starting on 6/8.  These are described by the mother as tantrums that are intense with writhing and kicking.  Behavior has been observed by family, not health professionals.  Reactions complicated because patient also swallowed an earring on 5/31, one day post MMR.  Child has had an abnormal pattern of bowel movements since passing the earring on 6/04/08.  Parent was strongly, strongly encouraged to seek medical care for the child.  The parent has communicated on the phone with the primary, but saw a physician in the ER for the earing incident the day it happened.  The child's primary was notified of VAERS and the child's periodic screaming and abnormal bowel patterns.
This case was reported by a physician via sales representative and described the occurrence of hives on chest in a subject of unspecified age and gender who was vaccinated with Havrix 720 (GlaxoSmithKline).  Concurrent vaccinations received the same day were unspecified, but may have included MMR.  In 2007 on an unspecified date within the last two weeks of this report, the subject received unspecified dose of Havrix 720 (unknown).  At an unknown time after vaccination with Havrix 720, the subject experienced hives on chest.  At the time of reporting the outcome of the event was unspecified.  The physician considered the event was possibly related to vaccination with Havrix 720.
Patient reported she had "blisters" develop to her right shoulder. She recieved H1N1 vaccine 01/09/2010 to right deltoid.
Booster doses of 0.5 ml administered instead of 0.25ml.  0.25ml was warranted dose for subject patient
RASH ON CHEST, ARM, AND SHOULDER AND A SORE ARM THAT PERSISTS
Patient arrives to the ED with complaints of cough, shortness of breath and vomiting that all started this morning otherwise healthy female in her 1st pregnancy presents with COVID infection. (7 months pregnant.
October 1, 2018 This patient was seen at Health Center on 9/27/18 for a flu shot. Flu Shot was done in his left arm around 3:00 PM. He states that after he left our facility he went to put in a drain system in a home. By 3:30 PM he was in the basement of this house, and stated that there was a strange odor. He states when he left the basement of the house to go upstairs, he couldn't remember where he was or what he was doing. He went home for a while and then someone took him to the ER. He states that the amnesia lasted several hours. BP was elevated for several hours according to the patient. He denied associated headache, nausea, or vomiting. He was evaluated for a stroke. Lab work was done. Toxicology was positive for marijuana. Imaging was done including CT Head without IV Contrast, which showed No acute intracranial abnormality. Portable Chest X-ray 1 view with result No acute finding in the chest. Echocardiogram complete with Bubble Study, result Negative Bubble Study without any evidence of interatrial shunt, no pericardial effusion. MRA Head without IV contrast, result Normal MRA of the brain. MRI of the Brain with and without IV Contrast. Result, Focal small T2 and FLAIR bright signal in the left high posterior parietal cortex which may represent small subacute ischemia. He was released from the hospital at 8:00 PM on 9/29/18. After the flu shot he never had a rash, shortness of breath or signs of anaphylactic shock. Dr., Medical Director for Health Center reviewed the information from the patient and the information from the Hospital. He felt that the patient had suffered a mild stroke from the report of the MRI of the Brain with and without Contrast and not the flu shot that had caused the Transient Global Amnesia.
Covid 19 breakthrough.  1st Vaccine on 02/01/2021.  Pt presents with c/o cough, SOB, Chest pain, fatigue and body aches.  Pt states tested + for Covid 11 days ago and was treated with decadron but symptoms did not improve.  Pt also had monoclonal antibodies 1 week ago.  She is immunocompromised and on Rituxan infusions(last dose Dec 20210 and weekly Hizentra.
Nausea, vomiting, diarrhea, fever 101-102F & febrile seizure. This seems apparent that pt. had stomach virus & timing was coincidental.
pt recv vax & was later found to be five weeks preg @ the time of vax;f/u was recv which indicated pt had an elective termination;
This spontaneous report was received from a healthcare worker referring to an unspecified number of patients of unknown age and gender. No pertinent medical history, concurrent conditions or drug reactions/allergies were reported. On an unspecified date, since 20-AUG-2015, the patients were vaccinated with an unspecified number of improperly stored doses of VARIVAX, (dose, frequency and route of administration were not provided), lot # reported as L015049, expiration date 29-APR-2017. No concomitant medication was reported. At the time of this report no adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
Shortness of breadth within 2 days of injection that was followed by  upper chest pain while taking a breath. I checked myself into Hospital.  They treated me for a day and then, due to the severity, sent me to another Hospital. My heart function was down to 7% and was very near death. I was placed on an ECMO machine to prevent my death. I was in this hospital for approximately 40 days and spent another 21 days in a rehab facility.
Swollen around eyes, red watery eyes. Developed massive hives and rash by evening. Took otc Benadryl. Went to ER 02/27/2011 for i/v steroid, Benadryl and Zantac type stuff. Went to primary doc 2/28. RX for prednisone and Atarax. Now 3/1, and new rash showing up quite a bit.
After completing the course of Paxlovid and being 10 days post initial symptoms I tested positive again on a rapid test after testing negative for 4 days prior; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (After completing the course of Paxlovid and being 10 days post initial symptoms I tested positive again on a rapid test after testing negative for 4 days prior) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939903) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Name of Drug as Reported-No). Concomitant products included ATORVASTATIN from an unknown date to 17-May-2022 for an unknown indication.    On 04-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (After completing the course of Paxlovid and being 10 days post initial symptoms I tested positive again on a rapid test after testing negative for 4 days prior). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (After completing the course of Paxlovid and being 10 days post initial symptoms I tested positive again on a rapid test after testing negative for 4 days prior) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative and positive (Positive) Positive.         The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient had previously received a COVID-19 Vaccine.   It was reported that after completing the course of Paxlovid and being 10 days post initial symptoms patient tested positive again on a rapid test after testing negative for 4 days prior. Company comment: This is a spontaneous case concerning a 43-year-old male patient with no relevant medical history reported, who experienced the non-serious, unexpected AESI event of COVID-19, which occurred on an unknown date after the third dose of mRNA-1273, thus latency between vaccination and the event cannot be assessed. It was reported that after completing the course of Paxlovid and being 10 days post initial symptoms patient tested positive again on a rapid test after testing negative for 4 days prior. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 43-year-old male patient with no relevant medical history reported, who experienced the non-serious, unexpected AESI event of COVID-19, which occurred on an unknown date after the third dose of mRNA-1273, thus latency between vaccination and the event cannot be assessed. It was reported that after completing the course of Paxlovid and being 10 days post initial symptoms patient tested positive again on a rapid test after testing negative for 4 days prior. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.