chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Placental insufficiency and severe IUGR (measuring 3+weeks behind) discovered at 20 weeks pregnant (2/14/22). Reverse flow in umbilical cord and high likelihood of intrauterine fetal demise
Headache, Myalgia, NauseaVomiting Clammy Narrative:
possible application of expired vaccines.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (possible application of expired vaccines.) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (possible application of expired vaccines.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (possible application of expired vaccines.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: Non-Significant follow up appended-Contact information ,dose no updated.
Pt was 6 days too old to receive the Rotateq vaccine, per MDH guidelines
Numbness in Left thumb extreme pain staring at shot site them moving up to shoulder/neck, shoulder blade, back of jaw.
12 days after first shot, I experienced extreme chest pain and heart arrhythmia.  I has to go to the emergency room and was hospitalized overnight. They performed echocardiogram, ct of chest, labs and venous dopplar. I was Diagnosed with new onset atrial fluttering and now seeing a cardiologist. I wore a heart monitor for 2 days and was told my heart paused/stopped 6 times and longest being for 8.6 seconds. I am scheduled for a TEE with cardio aversion, then a cardio ablation and /or pacemaker.
What is best for the minor discomfort from a shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced discomfort. On an unknown date, the outcome of the discomfort was unknown.   It was unknown if the reporter considered the discomfort to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient for himself/herself. The age at vaccination was not reported. The patient asked what was best for the minor discomfort from Shingrix.
patient experienced pain and swelling at injection site for 3 days after vaccine. He developed hives on scalp, face, neck and back that began on 11/6.  He developed a sore throat on 11/6 as well. He developed low heart rate on 11/7.
received first dose of covid vaccine on 2/2/2021.  Then hospitalized with covid disease / pneumonia on 2/12/2021
Abnormal vaginal bleeding; Pain in hips, knees, ankles; Painful lymph nodes on left side especially neck area; Spleen pain; Painful armpit left side; Diarrhea; Numbness and tingling in hands and feet; Numbness and tingling in hands and feet; This is a spontaneous report from a non-contactable nurse, the patient. A 36-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168), via an unspecified route of administration in the left arm on 15May2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD) from an unknown date. The patient did not have any history of allergies to any food or medications or other products. Concomitant medication included amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL) for an unknown indication from an unknown date and unknown if ongoing. 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 15May2021, the patient experienced abnormal vaginal bleeding, pain in hips, knees, ankles, painful lymph nodes on left side especially neck area, spleen pain, painful armpit left side, diarrhea first 2 days, numbness and tingling in hands and feet and then only tingling in fingertips of both hands. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken for the events. The clinical outcome of the event diarrhea was resolved on an unknown date in May2021. The clinical outcome of the events abnormal vaginal bleeding, pain in hips, knees, ankles, painful lymph nodes on left side especially neck area, spleen pain, painful armpit left side, numbness and tingling in hands and feet were not resolved at the time of report.    No follow-up attempts are possible. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2012, the patient was vaccinated with a dose of ZOSTAVAX, (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster (onset date was not provided). On an unknown date in 2016, the patient was treated by a physician for a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of 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 significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
No adverse event, gave incorrect dosage of pneumovax, should have been for Wyeth for age under 2, but gave Merck for age 2-18 yrs.
VIolent shaking for 2 hrs, horrible headache, fever, nausea, generalized skin pain, hair follicle pain, diarrhea, cramping, abdominal pain, face rash on left side and swelling in face, dizziness, abdominal distended, kidney pain, frequent urination, loss of appetite, bones felt frozen. And no  this isn't conversion disorder.
25SEP98 rt ear pain when swallows rt tonsil enlarged;nausea & generalized achiness;pt advised to call PMD & visit today;
Narrative: Patient reported altered taste, nightmares, and weakness after receiving first dose of covid vaccine.
Fever; Weakness; fatigue; Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever, weakness, fatigue and muscle pain. On an unknown date, the outcome of the fever, weakness, fatigue and muscle pain were unknown.   It was unknown if the reporter considered the fever, weakness, fatigue and muscle pain to be related to Shingrix.  Additional case details were provided as follows: The patient reported for himself. The age at vaccination was not reported. The patient experienced fever, weakness, fatigue and muscle aches after receiving Shingrix vaccine. The patient would not provide any additional details.
itchy; big lump; her arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of   in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included MESALAMINE for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Initial information received on 27-Nov-2018 regarding an unsolicited valid non-serious case received from a health professional. This case involves a four years old patient (gender not reported) who supposed to vaccinated with a 0.5 ml dose of QUADRACEL lot number-C5497AA Exp. Date- 17-Jul-2020 via intramuscular route in unknown administration site on 27-Nov-2018. It was reported that, we were giving a patient QUADRACEL and a fifth of the dose didn't go in. The patient's medical history were not reported. Concomitant medication included MMR. It was an actual medication error due to vaccine underdose. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Follow up information received from healthcare professional on 30-Nov-2018. Vaccine details including batch number, site, expiration date, concomitant added, outcome updated. List of documents held by sender: none.
No adverse effect; multiple unspecified patient have received improperly stored vaccines; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided.  On 30-MAY-2019, the patient received improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5 ml, one dose; lot# N028744, expiration date: 11-MAR-2020; route of administration was not provided). No adverse effects were reported. Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was stored in refrigerator and experienced temperature excursion of 28.2 degrees Fahrenheit (F) (1 cycle) for 19 hours. There was no previous temperature excursion. Digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA008227: US-009507513-1909USA005979: US-009507513-1909USA008230: US-009507513-1909USA008229:
Throwing up on 8/27/2014 & 8/28/2014,she became very weak. Cold like symptoms on September 1, 2014 that included a sore throat and Body aches. We noticed swelling of the tonsils on September 4, 2014. Went to a clinic on September 5, 2014 and was given Flonase for nasal drip but nothing else because they were testing for strep throat which was negative.  Went to Emergency  center on September 7, 2014 because she could hardly swallow and her tonsils were even more swollen with white spots on them. Was diagnosed with mononucleosis.
Papular rash lateral thighs at site of imms some excoriation suggestive of itching no treatment.
Received both doses (1st Jan 2021 and 2nd Feb 2021) of Covid vaccine. Developed chest pain and other cardiac symptoms resulting in a diagnosis of pericarditis and pleurisy in July of 2021 which lead treatment. Developed severe/debilitating hip pain July 2021 resulting in diagnosis 3 months later of diagnostic testing of Avascular Necrosis. Prognosis concluded total joint replacement required on bilateral hips (R 12/20/21 & L 5/20/22) Developed severe knee pain on Dec. 2021 resulting in more diagnostic testing with concluding AVN in bilateral knees requiring joint placement. Left shoulder pain developed in 05/2022 resulting in diagnostic testing concluding avascular necrosis which will also need total joint replacement. Attempted core decompression to left knee on 08/05/22 to relieve severe pain with no success noted at this time.
Shoulder and neck pain; Shoulder and neck pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  An 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation; pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Blood pressure high" (ongoing), notes: taking blood pressure medications; "Dialysis" (unspecified if ongoing), notes: Dialysis. Concomitant medication(s) included: LOSARTAN taken for hypertension; METOPROLOL taken for hypertension; HYDRALAZINE taken for hypertension. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization.  The following information was reported: ARTHRALGIA (non-serious), NECK PAIN (non-serious), outcome "unknown" and all described as "Shoulder and neck pain". Therapeutic measures were not taken as a result of arthralgia, neck pain.  Additional information: Two or three weeks ago, the patient had also a pneumococcal shot. I have a caller on the other line. She is a consumer. She is reporting that she has shoulder and neck pain after receiving the COVID-19 vaccine, the booster dose and she would like to know if this is one of the side-effects of the booster dose.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Fever 102 & vomiting 9/11/12. PE - slightly red posterior pharynx. CBC WBC - 9.7 Poly - 54 Mono - 11.9; Lymph 33.4 H/H 13/41 platelets 211 Rapid strep test (-) Flu A/B tests (-)
Information has been received from a nurse practitioner concerning a female patient who in 2008 started the series of GARDASIL. Concomitant therapy included (ADVAIR), (CELEXA), (ATIVAN) and hormonal contraceptives (unspecified). It was reported that the patient tested positive for herpes simplex virus after receiving all three doses of GARDASIL vaccine. The patient did not have any symptoms of herpes simplex, but HSV IgG and IgM test showed positive. The patient was seen by the nurse practitioner for medical attention. At the time of reporting the patient had not recovered. Additional information has been requested.
Information has been received from a health professional concerning a 46 year old male who in March 2000 completed the adult schedule of varicella virus vaccine live (lot # 631071/1002J). A recent titer did not show seroconversion. No other information was available. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
After the shot I had a headache and soreness. About 11 hours later I started getting a fever and chills. I took nyquil to sleep and during the day I used Tylenol to alleviate the chills from the fever.  Over 24 hours the fever and chills are worse and my entire body aches along with a headache.
Myalgia Narrative:  Arm soreness, redness and a large lump under the  skin. Muscle aches, Fatigue: Sleeping 15-20 hours a day since 2nd vaccine.
Breakthrough Case of COVID-19: I started having COVID-19 symptoms, I took two at home COVID-19 test and I tested positive. I went to the doctor and had another COVID-19 test and confirmed I tested positive for COVID-19. I had a runny nose, fatigue, and a slight fever. I was not prescribed anything and was told to quarantine, take plenty of fluids, and rest. I still have a cough but I am not as congested as when I first tested positive.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "known allergies: Tetracycline". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: first positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
stomach issue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EL9269) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Blood pressure. Concomitant medication(s) included: METOPROLOL. The following information was reported: GASTRIC DISORDER (non-serious), outcome "not recovered", described as "stomach issue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of gastric disorder.  Additional information: Consumer stated, Well, she wanted to ask you, do you have knowledge of the side effects for the Pfizer COVID Vaccine? She had had a couple and she wanted to see if anybody else has reported it. Consumer was informed about the role of Pfizer Drug safety and Pfizer Medical information for the concern. In response: Consumer stated, Yeah, are they closed already. Consumer was provided with the number of Pfizer Medical Information # (Phone number) and was requested to select op-tion 3, timings as 8 am to 9 pm Monday to Friday. The patient stated, "Whenever she had the first one back to the first one now, she had stomach issues couple of days after, a day or two after and she called the other night and asked if that was one of the side effects and they really don't know whole lot about it but they put it down. Then she had second and third one and she did okay, but she had fourth one and was having really bad stomach issues and had been to the doctors and I couldn't find anything wrong with me or anything else because of this problem." First shot: 06Feb2021, Second shot: 27Feb2021, Third shot: 09Oct2021 and Fourth shot: 01Aug2022. Consumer stated, "It looks like its EL9269 for the first one. Then EL9266 (Second shot), and then FF2589 (Third shot) and then the next one is, she couldn't read it. F something, maybe 7137 (Fourth shot)." She was taking Blood pressure medication, Metoprolol. She had a lot of lab tests in this 3 weeks. She had lab work done on 30Aug, and back in 15Aug. What do you mean by name of the lab work? It was done in the hospital. Oh what did I check for in my lab work? The test performed, is that's what you want to know? There is General order, Infectious disease, Cardiac monitor, Triage abdominal pain, regular lab, just general lab work on here, what it says." (Further clarifications unknown).She had a MRI done and a CT scan done, both with contrast to see if she could find something wrong with stomach. She couldn't find anything. She had been taking Bentyl and trying to get that to work Nothing was helping with it, nothing at all. It comes and goes but it would not go away. No Prior Vaccinations (Within 4 weeks).; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201131869 Same reporter/Patient/event; different Dose;
Patient said she experienced a red non itchy rashed that developed on one side of her back and wrapped around her side two days after getting her first Shingrix vaccine.  It went away after 2 days.  She notified her doctor, who asked her to stay for observation after her second Shingrix dose to watch for anaphylactic reaction.
Wed. Feb. 24 - 4:30 pm - felt flushed, upon removal of mask face was bright red and stayed that way for 3 hours.  Developed what felt like swollen glands and sore throat 2 hours later which lasted for 2 days.  Pain in left arm for three days.  Friday, Feb. 26 11:30 pm - terrible vertigo, felt room spinning and had to hold on to furniture to prevent falling.  Went to bed and the entire room was spinning.  Bad vertigo the next day Saturday, Feb. 27 so stayed in bed.  Was better in the afternoon but still felt very dizzy and had to stay in bed all day Saturday.  Sunday, Feb. 28 felt much better and was able to cook meals but still felt tired and on the verge of dizziness.
This non-serious spontaneous case, was initially received on 28-Sep-2017 from other health professional concerning a 56-year-old, adult female patient. The patient's medical history and concomitant medications were not reported. On 27-Sep-2017, the patient was administered with expired FLUCELVAX QIV (dose: 0.5 ml, batch number: 185286, expiry date: 30-Apr-2017, route of administration, anatomical location: not reported). It was reported that the patient was administered with last year's FLUCELVAX that expired on Apr-2017. The reporter assessed the report as non-serious. Non-significant case correction received 28-Sep-2017: Batch number (185286) was added on the screen and updated expiry date. The narrative was amended accordingly.
redness, heat, and swelling at the injection site. three and a half inches by 5 inches and expanding. went to the urgent care and the provider prescribed antibiotics, taking the antibiotics if the symptoms worsen in the next 24 hours.
Fatigue and arm soreness same day, next morning severe headache/migraine, mild hypothermia (temperature of 95.6 °), vomiting
This study case was received from the investigator on 22 February 2012. A subject (age, date of birth and gender not reported) had received an injection of ACAM2000 and an injection of ANTHRAX VACCINE (lot numbers, routes and sites not reported) on 16 March 2011. The subject was diagnosed with unspecified disease of pericardium on 04 April 2011. Medical history was not reported. No further information was available at the time of the report. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.