chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Zostavax vaccination 12/15/06. Seen in office 12/18/06 - redness to site/ upper arm. Seen 12/27/06 - urticaria, slightly raised, maculo-papular lesions over torso, extremities and head. Zyrtec, Benadryl as needed.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 1:29 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 1:29 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 68.18 for dose administered on 31-Mar-2021. No concomitant medications were reported. Batch number 030B21A underwent temperature excursion on 31-Mar-2021 with temperature 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 31-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a temperature monitor at every hour. No treatment medications were reported.
Vasovagal syncope x2 about 5 minutes after injection then followed by in about 5 more minutes by nausea with vomiting. A few minutes later began crying, complaining of lower back and flank pain 7/10.  EMS called and transported to ER.
Recieved vaccine on 6/7/21 started to feel adverese reactions such as fever of 102, chills and hot flashes, began having lupus flareup in right side of chest that made it feel as thpugh I could not take a deep breath, have suffered with chostrocondritis since lupus diagnosis in March of 2021. These flare ups continued and increasingly got worse after the 2nd dose of the Pfizer vaccine. This led to Emergency Room visits, 2 to be exact. Chest CT's with Contrast and copious amounts of blood work to check for PE's and inflamatory markers. Blood work came back with highly elevated inflammatory markers and elevated WBC. CT showed inflammation and unknown tissue formation on Thymus. Have had ongoing lupus flareups since.
15 min after receiving the shot I could taste it meaning I could literally taste the medicine in my mouth. A couple hours later I experienced itching throughout my body more on my arm back and neck.  I thought these things would go away and this morning I can still taste the vaccine.  It tastes bitter. It tastes mediciney like saline mixed with something which in turn is making me nauseated because I can't get this taste out of my mouth. I can taste foods n things just fine but it's like the medicine is absorbed through my skin or something.  I am also itching everywhere. My back on the right side mainly but also other parts of my body but it kind of hurts and burn a little on that whole right side kinda like hives but no red rash on the backside just injection site.  I also am experience headaches. I went to work at 6:40 am and my head was pounding. I rarely have headaches but I was completely healthy before this. I was living my best health life before this. This vaccine was not made for me. This is also causing me to lose hours because I can't think if I'm in this much turmoil behind it.
I just recently had COVID 11 days after I've been vaccinated with your product; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of COVID-19 (I just recently had COVID 11 days after I've been vaccinated with your product) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I just recently had COVID 11 days after I've been vaccinated with your product). At the time of the report, COVID-19 (I just recently had COVID 11 days after I've been vaccinated with your product) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Stents installed. One was in May2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56-year-old female patient received bnt162b2 (BNT162B2), on 21Apr2021 as dose 2, single (Lot number: ER8735) at the age of 56 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE; Batch/Lot number: ER8735; Time: In the morning, between 8-10am), administration date: 31Mar2021, for COVID-19 Immunization. The following information was reported: STENT PLACEMENT (medically significant) with onset May2021, outcome "unknown", described as "Stents installed. One was in May2021".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300367690 Same patient/vaccine, different dose/events (dose 3);
Red skin/hives on my chest one-two minutes of vaccine administration. My muscle tensed up as the vaccine was injected and the person giving my shot said that she never experienced it before. Arm had a weak feeling. Runny nose as I was being taken down to the emergency room.
Within 5 hours I felt as if I was in a fog.; I was driving home and felt as if I had been drinking alcohol (I didn't); Fever; Chills; Very bad headache; I still feel very sick today; I was very fatigued after the first dose but this is much worse; This is a Spontaneous report from a non-contactable consumer (patient). A 48-year-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 12Feb2021 at 13:00 (at the age of 48 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have any known allergies. Historical vaccine included first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on 22Jan2021 (at the age of 48 years old) for covid-19 immunization and patient experienced very fatigued after the first dose. The patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 12Feb2021 at 18:00, within 5 hours patient experienced felt as if she was in a fog. She was driving home and felt as if she had been drinking alcohol (she didn't). 12 hours after, she woke in the middle of night with fever, chills and a very bad headache. She still feels very sick today. She was very fatigued after the first dose but this was much worse. The patient did not received treatment due to the events. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Doses were administered to patients from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior; Vial stored post puncture vial was stored under refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered to patients from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior) and PRODUCT STORAGE ERROR (Vial stored post puncture vial was stored under refrigerator) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced PRODUCT STORAGE ERROR (Vial stored post puncture vial was stored under refrigerator). On 23-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered to patients from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered to patients from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior) and PRODUCT STORAGE ERROR (Vial stored post puncture vial was stored under refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. On 31-Mar-2022, The vial was initially stored in the refrigerator. On 21-Apr-2022 at 10:20 am, The vial was first punctured. On 23-Apr-2022 at 9:50 AM - 4:05 PM, patient received second booster dose.  The patient has not reported any adverse reactions to the expired dose administered.  Post puncture vial was stored in refrigerator and the vial did not undergo any temperature excursions. The vial was not exposed to room temperature for more than 24 hours. No treatment drug was reported.
No adverse effect; Administered a dose a week before turning one year old; This spontaneous report was received from a nurse regarding a patient of unknown demographics. The patient's relevant history, concurrent condition and concomitant medications were not reported. On 18-MAY-2019, at the age of 11 months (also reported as one week before turning 1 year old), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, unit, lot#/expiration date and anatomical location: unknown) reconstituted with sterile diluent injection (product administered to patient of inappropriate age). The reporter informed that there were no other adverse effects reported (no adverse event).  There was no product quality complaint associated with this report.
This prospective pregnancy case. This 35-year-old female subject was enrolled in a study. The subject received FLUARIX on 20th October 2014. The subject's estimated date of delivery was 12th November 2014. The subject received FLUARIX at week 35 of the pregnancy and during the third trimester of pregnancy. On 20th October 2014, an unknown time after receiving FLUARIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.
Both arms, and only the arms, became swollen, red with rash, itchy and painful. Other more common side effects included fatigue, chills, nausea, severe headache, which occurred in the evening of the day vaccine was administered
On July 6th,2022 I was admitted to the hospital for 3 days, after being rushed to the Emergency Room after having a TIA Stroke
did a CT and the doctor says I had pneumonia by COVID, because my lungs were bad with symptoms; did a CT and the doctor says I had pneumonia by COVID, because my lungs were bad with symptoms; did a blood test and they gave me an antibiotic for 7 days; did a CT and the doctor says I had pneumonia by COVID, because my lungs were bad; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration in the left arm on 22Feb2021 10:30 (Lot Number: EL9266) as a single dose; and dose 1 via an unspecified route of administration in the left arm on 01Feb2021 13:30 (Lot Number: EL9266) as a single dose for covid-19 immunisation. The patient medical history was not reported. The patient was not diagnosed with Covid-19 prior to vaccination. There were no concomitant medications. The patient received the vaccine in a hospital. The patient did not have other vaccine in four weeks. The patient mentioned that the second shot on 22Feb2021. On 15Mar2021, he was coughing and feeling tired. He mentioned that he went to urgent care and did COVID test, but the result was negative. On 25Mar2021, he stated that he was worse and went to another urgent care. He did a blood test on an unspecified date in 2021 and they gave him an antibiotic for 7 days. On 03Apr2021, he was really bad and went to an ER emergency. They did a CT on an unspecified date in 2021 and the doctor said he had pneumonia by COVID, because his lungs were bad. The patient inquired if that was possible and they wanted to check if the vaccine wasn't efficient for him. The outcome of the events was unknown.
Had 2nd pneumococcal vaccine at 2200. Developed exquisite pain, swelling, erythema, couldn't lift objects.  Swelling, extended to elbow.  Last pneumococcal shot 9/14/93.
administered with an expired dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired dose of the Moderna Covid-19 vaccine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired dose of the Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with an expired dose of the Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment information was not provided
Large round red circle (tennis ball size) at the injection site just showed up.  It's a little itchy.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On an unknown date the patient was vaccinated with ROTATEQ (strength, dose and lot number unspecified) orally, which underwent a supported temperature excursion (Incorrect product storage). No adverse effects were reported. This is one of the 23 reports received from the same reporter. Additional information has been requested.
This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. 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: unknown, expiry: unknown), dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced multiple deep vein thrombosis (DVT's) and multiple pulmonary embolisms (PE's) after receiving Johnson and Johnson vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the multiple deep vein thrombosis after receiving vaccine and multiple pulmonary embolisms after receiving vaccine was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220403496-COVID-19 VACCINE AD26.COV2.S-  Multiple Deep vein thrombosis after receiving vaccine ,Multiple Pulmonary embolisms after receiving vaccine The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Fatigue, Migraines, and severe longterm vertigo every day since I got the shot. It's been 4.5 weeks. I am seeing specialists. It is a disability. I'm unable to work, do house chores, and drive as much as I need.
swelling in the injection site; lump in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling in the injection site) and VACCINATION SITE NODULE (lump in the injection site) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling in the injection site) and VACCINATION SITE NODULE (lump in the injection site). At the time of the report, VACCINATION SITE SWELLING (swelling in the injection site) and VACCINATION SITE NODULE (lump in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Relevant concomitant medications were not reported.  The treatment information was  not provided.    Reporter did not allow further contact
The patient received their Booster dose of Pfizer COVID-19 vaccine in the evening of 2/16/22. The patient woke up the next morning 2/17/22 with hives on her extremities and hips. She also experienced red itchy eyelids and swollen lips. The mother reports that these symptoms lasted from 2/17/22-2/25/22. After the symptoms improved on 2/25/22, the patient began experiencing itchy eye lids again on 3/1/22. The patient's mother has contacted the primary care physician regarding this issue.
24-36hr p/vax pt devel vasculitic rash that affected trunk/extremities exp malaise & a 5 days worsening of oxygenation;
In mid September became breathless on Sunday and continued getting worse until Thursday night and called 911 at 1 AM. Admitted to er, discovered had a Saddle Pulmonary Embolism.
Vial was initially stored in the refrigerator on 11AUG2022, vaccine administered on 26-SEP-2022; No adverse event; Patient received vaccine after the 30 days beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 11AUG2022, vaccine administered on 26-SEP-2022) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 11AUG2022, vaccine administered on 26-SEP-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 11AUG2022, vaccine administered on 26-SEP-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 11AUG2022, vaccine administered on 26-SEP-2022).    No concomitant medication information was provided. The vial size was reported as 2.5 ml. It was reported that Lot 055A22A was moved from the freezer to the refrigerator on 11AUG2022.. It was reported that the vial did not undergo temperature excursions. They had multiple doses administered after the 30 days beyond use date. None of patients reported experiencing any symptoms after receiving those doses.  No additional doses, medications or treatments had been administered in response.   This case was linked to US-MODERNATX, INC.-MOD-2022-654159, US-MODERNATX, INC.-MOD-2022-654164 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654159:Patient 6 (same reporter) US-MODERNATX, INC.-MOD-2022-654164:
Spontaneous and acute urticaria consisting of hives, red blotches, red lines, and red streaks that have persisted since the onset date of symptoms (18-Dec-2021).  Timeline: 18-Dec-2021 / 11:45: Urticaria present with small, red hives on lower back; sparse. 19-Dec-2021 / 21:00: Urticaria present with small, red hives on chest, shoulders, and lower back. The number of hives increased as compared to previous timestamp. Small, circular red blotches started to appear on chest.  20-Dec-2021 / 07:30: Urticaria present with small, red hives on chest, shoulders, and lower back. Small, circular red blotches persisted on chest. Hives started appearing on both arms (upper and lower) and spread to hands. Itching started to occur.  20-Dec-2021 / 12:00: First appointment with Primary Care PA (Physician Assistant). Urticaria present with similar breakout as described in previous timestamp.  20-Dec-2021 / 14:00: Urticaria rapidly started to worsen. Red lines and red streaks starting to appear on neck, shoulders, lower back and abdomen. Hives present on arms (upper and lower) to wrist and hands. Blistering on the inner part of bicep on right arm. Itching persisted. 20-Dec-2021 / 16:00: Emergency Response (ER) visit. Benadryl administered and Solu-Medrol via IV. Urticaria persisted with all of the same symptoms, and started to also appear on legs and feet. 10% improvement upon leaving the ER facility. 21-Dec-2021 / 20:00: All symptoms still persist. Itching. Starting to see red blotching (minor) on chin, just below lower lip. Lower lip is slightly puffy.   2x Benadryl every 4 hours 1x Zyrtec daily 1x Prednisone every 6 hours, 10mg