chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized and died due to COVID-19 after being fully vaccinated.  From vital records:  ACUTE RESPIRATORY FAILURE WITH HYPOXIA, PNEUMONIA DUE TO COVID-19
PATIENT HAD FEBRILE SEIZURE THE SAME NIGHT AFTER VACCINE ADMINISTRATION.  2/2/09 MR received for ER visit 12/23/08 with D/C DX:  Febrile Seizure.   Pt presented after an episode of generalized rigidity with eyes rolling back with LOC, lasting ~2 minutes.  Temp 99'F at home,  104'F in ER.  PE otherwise WNL. D/C to f/u with PCP
I had severe fatigue, headache, sinus congestion and pressure that lasted for day and ear inflamation. I was seen at Urgent Care.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. 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 (dose number in series 1) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient was sick of corona for four days (suspected covid-19 infection and suspected clinical vaccination failure) (dose number in series 1). Patient stated, "I've been sick of corona for four days you have scammed me JNJ pfizer". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported (dose number in series 1). The patient additionally received BNT 162 (Pfizer vaccine) (dose number in series 2) (form of admin, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with BNT 162 (dose number in series 2). This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000217345.; Sender's Comments: V0:20220231913-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Really strong left arm pain around injection site.  Not able to extend or retract my arm for the day after injection. Was really painful, couldn't sleep or apply pressure to arm, also at one point I had an extremely sharp/shooting pain that was in my left arm/neck. Currently 5 months pregnant, due June 7th 2021
081902 come to get # 2 Hep B Ad reports she broke out in rash that was around her waist 3-4 days after vaccine. Looked like blisters, but did not drain c/o itching-no pain. Rash did not clear up until Aug. 2nd/3rd. Denied headaches, nausea,synapse, chest pain, or sob. No new skin products, no change in soaps. Told pt to check with PMD before continuing services.
Woke up one morning felt pain in left leg there was a red streak from ankle to groin on the inside of my leg left.  Pain continued to get worse vein became inflamed puffed up and harden.  Sought care of primary care doctor. Diagnosed as blood clots scheduled for ultra sound of vein.  prescribed blood thinner elequist and antibiotic augmentine.  Had ultrasound performed  2/13/2023.   Ultrasound showed a blood clot in vein near knee shallow.  After receiving treatment symptoms subsided in week to 10 days.
This spontaneous report was received from a medical assistant who refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N017700, expiration date: 09-JUN-2019, dose, strength, frequency and route of administration were not provided) for prophylaxis. The vaccine was diluted with properly stored dose of sterile diluent (manufacturer unknown). The vaccine was stored between 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour 9 minutes prior to administration. Previous temperatures excursions: 6 degrees Fahrenheit to 14 degrees Fahrenheit for 76 minutes and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour and 23 minutes. The call was because of digital data logger. No adverse events were reported. Product quality complaint was not involved. This is one of several reports form the same reporter. Sender's Comments: US-009507513-1711USA002012.
It started with a slight cough, stinging in my chest with respirations and wheezing. I was diagnosed with severe bronchitis due to COVID-19. I tested positive at my doctor's office where I was tested for COVID-19 and strep throat on 03/13/2023; I came back positive for COVID-19 and negative for strep throat. I was prescribed Paxlovid and an albuterol sulfate inhaler for treatment. As of now, I'm doing much better and fine by the end of the first day of treatment.
He got meningitis a little more than a month later. The doctors stated he probably got bit by a mosquito. If he was ever outside he was covered completely and it was for about 5 seconds to go from the house to the car. Lets be honest, I had twins so we did not leave the house for awhile. He never had a bite mark. It was very sudden. He was hospitalized for two days, given antibiotic. Currently, he has recovered.
This spontaneous report as received from a healthcare worker, refers to unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, since 12-JUN-2015, the unspecified number of patients were administered an unspecified number of improperly stored doses of GARDASIL (lot # K005881, expiration date 14-JAN-2017), intramuscularly (dose, frequency, indication were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Presented 1/27/09 with Zoster L1 dermatome.Recieved Varivax 4/27/04 and ProQuad 11/14/06
Received vaccine Oct 11, experiened achiness Oct 16, bronchitis, serous otitis with diagnosis Oct 19.  Reaction to flonase, zithromax including oral candida  and diarrhea with additional treatment of bronchitis and yeast infection required Oct 25.Unable to document fever at home, visits to urgent care x3 did not reveal elavated temperature.  Did not feel unusual level of wellness for two weeks.
The patient supposed to receive V ARlV AX and MMR II but the patient received V ARlV AX and PROQUAD; The patient supposed to receive V ARlV AX and MMR II but the patient received V ARlV AX and PROQUAD; This spontaneous report as received from a Licensed Practical Nurse refers to a 13-month-old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 04-NOV-2021, the patient was supposed to receive varicella virus vaccine live (oka/merck)(VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) but due to human error the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # T032932 was confirmed to be valid, expiration date 28-SEP-2022, 0.5 milliliter once (route of administration, anatomical location were not reported) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter once (route of administration, anatomical location, lot # and expiration date were not reported); both for prophylaxis (wrong product administered and accidental overdose).
First dose Nov 6th 2018, never got second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix vaccine (1st dose received on 6 November 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's Comment: The reporter was a pharmacist. The reporter stated that the patient never got the second dose of vaccine. The reporter consented to follow up Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Had dizziness, nausea, headache. I had to lie down for most of the day. By the next day I felt better but still had some symptoms.
Pain in the arm; Feeling tired; Feeling a little off; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date in Jan2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller reported that her daughter had the first dose of the Pfizer COVID-19 vaccine 3 weeks ago and had adverse events like pain in the arm, feeling tired, and feeling a little off on an unspecified date in 2021. After receiving the first dose of the vaccine her arm was killing her. Now 3 weeks later mom explains that her daughter still feels off, she feels tired and her arm still hurts. She would like to know if that was normal as her daughter is due for the second dose on Friday (05Feb2021) and she still has the pain in her arm and still feels a little achy and off. She wanted to know if it has been reported in the clinical trials. The outcome of events was unknown.   This follow-up (Case closure) 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.
red circle at the vaccination site; rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red circle at the vaccination site) and VACCINATION SITE RASH (rash) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red circle at the vaccination site) and VACCINATION SITE RASH (rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (BENADRYL ALLERGY & COLD) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (red circle at the vaccination site) and VACCINATION SITE RASH (rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
My right hand became inflamed and painful. (12/01/2021) I went to the doctor and she ordered a rheumatoid (negative) and a ANA Titer (Positive). 3/21/2022 Is when I went to the rheumatologists who did 14 test 2 X-Rays and the rest blood work. X-Ray found some issues on my hands. The right shows major arthritis issues and left a few issues as well. I have an appointment on 4/15/2022 to discuss findings with my inflammation.
nausea/ nauseous; headache; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea/ nauseous), HEADACHE (headache) and FATIGUE (exhausted) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included DIAZEPAM, OLANZAPINE, TRAZODONE, PROPRANOLOL, HYDROXYZINE and IBUPROFEN (IBUPROFEN) for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nausea/ nauseous), HEADACHE (headache) and FATIGUE (exhausted). At the time of the report, NAUSEA (nausea/ nauseous), HEADACHE (headache) and FATIGUE (exhausted) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information for the events was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: NNI case ,no new information was provided.
Second shot at 08/05/2021. Planed to be pregnant. Signs implied implantation. Period due at 08/09/2021 and came on time but with unprecedented pain so extreme that we called 911.  The pain persisted for 30 minutes. After took pain-killer, Advil, the pain subsided and disappeared.
About a month post vaccine - noticed left upper arm was still a little larger (swollen) than right arm.  By 01/19/22, had elbow bursitis in Left elbow - swelling continued down forearm and whole area became very red/inflamed, swollen, painful.   Left hip area was very painful about 1-2 weeks prior to this.        Sought help at Urgent Care on 01/20/22 - started Prednisone and Cephalexin which helped tremendously.    Still have a minor swelling and tenderness of Left elbow to this date
got a flu shot, then got the flu/suspected vaccination failure; flu; was down for 2 weeks; This case was reported by a consumer via other manufacturer and described the occurrence of vaccination failure in a elderly female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included lenvatinib mesilate (Lenvima) (batch number 2750055, expiry date 28th February 2025) for product used for unknown indication.   Concurrent medical conditions included penicillin allergy and sulfonamide allergy. Concomitant products included ibuprofen (Motrin Ib), olmesartan medoxomil and paracetamol (Tylenol).   On an unknown date, the patient received Flu vaccine and Lenvima (oral) 14 mg once daily (14 mg daily). On an unknown date, unknown after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and sickness. The action taken with Lenvima was unknown. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza and sickness were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, influenza and sickness to be related to Flu vaccine.     Additional Information: GSK receipt date:23-Nov-2022 Reporter's comment: The patient was advised that she got a flu shot them after getting the flu and was down for 2 weeks. The patient also received Lenvima. The patient was good now. The physician was aware. No further information was provided. Additional supportive information: It was unknown if the reporter considered the influenza and sickness to be related to Lenvima.  This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of influenza were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This case was reported by a physician's office manager and described the occurrence of hepatitis b surface antibody negative in a female subject of unspecified age who was vaccinated with DTPa-HBV-IPV (manufacturer unspecified), ENGERIX B. In 1995 the subject received 1st dose, 2nd dose and 3rd dose of DTPa-HBV-IPV (unknown details) on a 2, 4, and 6 month schedule. In February 2013 the subject received 4th dose of ENGERIX B (unknown details) and experienced extra dose administered. The subject had received a completed hepatitis B vaccination series in 1995. In February 2013, 18 years after vaccination with DTPa-HBV-IPV, the subject experienced hepatitis b surface antibody negative. "Titers for anti-HBsAg [antibody to the hepatitis B surface antigen] are now less than 0.1 mIU/mL." The physician reported another case with similar events. See case A1011474A for details on the other case.
stomach upset  and then felt "hot and cold" and Temp was 99.3.  Relieved with Tylenol and sleep. Next morning felt "blah" and slept and symptoms resolved
I had nausea at 07:00 pm for a few hours. That was my only symptom. Then I had nausea the second night for about 2 hours. On day three or four, my stomach started to hurt. I kind of felt like I was going into a Crohn's flare-up. I was still having it when I  had my second shot on October 15th.  After my second shot, I went and was having abdominal pains and that was October 20th. I went in on the 20th and they did a renal scan. I went into severe abdominal pain that day and I went to the hospital ER - Hospital on the 21st due to this pain. They did a CT scan. They gave me Morphine for the pain. And IV fluids. They sent me home with some sort of a intestinal pain medication to help my intestines not be in pain. They sent me home with almost like with a prep kit for a colonoscopy. They sent me home with another medication to take at night for five days. I don't know what that one was for. I took 2 pills a night for five days. Last Friday, the 5th, they had me go in and do an abdominal ultrasound. I'm still having this pain. I can typically pull myself out of a Chrohn's flare up with dietary measures but it isn't working. I called my doctor's office this morning and I'm hoping they are going to call back today. I'm still in pain and diarrhea and am discharging mucus with or without the diarrhea. I am not able to keep food in my digestive tract - within an hour after eating, I'm going to the bathroom.
Patient received additional dose of Sero groups A, C, W, and Y. Should have received sero group B instead.
Information has been received from a health professional concerning a 7 year old patient who on 07-SEP-2000 was vaccinated with a dose of Varivax. It was reported that the patient experienced vaccine failure. The patient was evaluated by a medical doctor. Additional information has been requested.
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Follow Up received: patient initials added
Pain at injection site (L) upper arm that radiates to (L) axilla and down her arm. Rash left - right side of trunk.
Low body temperature after physical exertion. Measured at 94.6 degrees when symptoms first appeared. Other symptoms include profusive sweating, joint pain, chills, fatigue, and tremors. Similar sensations as a fever. Increasing my body temperature via heaters, hot showers, and warm drinks temporarily alleviated these symptoms, but they returned with any moderate physical exertion. This lasted for 4 days.
March 10, 2021 I received my second dose of the Pfizer vaccine and the following day I experienced the predicted side effects of fever, chills, headache, fatigue and lack of appetite, which were all mild and I took Tylenol for the fever. The following day I was fine. After approximately two weeks I noticed there were subtle and unusual changes regarding my appetite, energy level an itchy rash on my back and a runny nose.  I didn?t pay much attention to any of these as they weren?t debilitating symptoms, but very unique for me. Then I realized I needed to pay more attention to these symptoms as they were getting more significant, except for the fact I didn?t have a fever.  Also my ears felt they were blocked.  I thought perhaps because of the feeling of blocked ears I may be getting a sinus infection although I haven?t had one in years. I called the doctor?s office on April 5th and I was told to go to the Urgent Care, which I did.  I was examined and given a prescription for a nasal spray, antihistamine and an antibiotic in case symptoms became more severe. It was also suggested that I may want to have a Covid test. I?m not used to taking any medications except for Trazodone, and was reluctant to take what was prescribed because if it was indeed a sinus infection it wasn?t in line with any I?d had years ago. I used the nasal spray for a few days and also the antihistamine. The headache got worse, and would move from one area of my head to another and also down the side of my face and neck. Tylenol didn?t help and Ibuprofen only helped now and again. The headache had a mind of its own. Warm compresses did help. I was in contact through the portal for recommendations from the medical staff.
Vaccine given outside of approved guidelines regarding age of recipient - client receiving vaccine was 14 years of age.
Treatment of COVID-19; Treatment of COVID-19; Dose Number: 5:Moderna/Dose Number: 4: Moderna/Dose Number: 3: Pfizer /Dose Number: 2: Pfizer/Dose Number: 1: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 08Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 22Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergic rhinitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25May2022, outcome "unknown", described as "Dose Number: 5:Moderna/Dose Number: 4: Moderna/Dose Number: 3: Pfizer /Dose Number: 2: Pfizer/Dose Number: 1: Pfizer"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 and was treated with Paxlovid start date 09Nov2022 to stop date=14Nov2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the nature of the events vaccination failure, covid-19, a causal relation between the reported events and the administration of the vaccine BNT162b2 cannot be excluded.