chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed profuse bloody diarrhea and lower abdominal pain beginning ten days after vaccination on 4/17. Went to see Dr who performed lab work and stool tests that all came back negative (4/19). Was treated with Zithromax but had no resolution to his symptoms.  No family history or prior history of IBD. It seems the onset of disease is clearly temporaly related to the timing of his Pfizer vaccine.
Discharge Provider: MD Primary Care Provider at Discharge: DO  Admission Date: 7/14/2022 Discharge Date: 7/20/2022  PRESENTING PROBLEM: Hyponatremia [E87.1] COVID-19 [U07.1]   HOSPITAL COURSE:    Patient is a very pleasant 90-year-old lady with past medical history reviewed and noted who initially presented to the ER on the 13th with diarrhea cough diagnosed with COVID and hyponatremia sent home on Imodium.  She returns with fatigue body aches and weakness and was admitted for further evaluation.  She recently lost her home to a house fire is currently residing in a hotel with her grandson.  Her sodium was 125 on presentation and he is 131 on discharge.  Patient is chronically hyponatremic.  Patient also had abrasions on her legs and both legs were x-rayed.  There was some comment regarding a lucency which could possibly be a small fracture in her left ankle.  However patient had no pain and could weightbear and walk without difficulty.  Patient is to follow-up with her primary care physician to see if this warrants further evaluation.  She was also noted to have renal insufficiency and her discharge creatinine is 1.15.  She did complain of right wrist pain swelling an x-ray showed concern for possible gout or pseudogout.  She did receive Solu-Medrol/prednisone/colchicine renally adjusted and had improvement in her symptoms and swelling.  She is encouraged to follow-up with her primary care physician for further evaluation and monitoring of renal function.  She was discharged on a short course of prednisone and colchicine.  Her blood glucose levels did increase with Solu-Medrol and she is encouraged to monitor her blood glucose levels.  She was evaluated by PT OT and it was recommended that she continues PT exercises at her hotel.  She was discharged in good condition back to her hotel.
Lots lesions on scalp - started as blisters then excoriated - crusty.
Information has been received from a medical assistant concerning an 8 year old patient who was vaccinated with a varicella virus vaccine live (Oka/Merck) (Lot #659533/1594U). Subsequently the patient developed an injection site reaction described as injection site swelling and injection site itching. The patient sought unspecified medical attention. There was no product quality complaint. This report is one of several from the same source. Additional information has been requested.
pt mom report pt exp high pitched screams until pt about passed out & diff w/swallowing; 2oz taken since 5AM;instructed to report to MD ;pt taken to MD for eval & MD confirmed c/o not d/t immun but rather a viral sore throat;
joint pain; sweating; nausea; This is a spontaneous report from a contactable consumer or other non HCP (Patient himself). A male patient of an unspecified age (age: 42; unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 24Jan2021 as DOSE 1, SINGLE for covid-19 immunisation and experienced hot & cold sweats at night. The patient received his first Pfizer BioNTech Covid 19 vaccine on 24Jan2021. He experienced hot & cold sweats at night. The patient received his second Pfizer BioNTech Covid 19 vaccine mid to late Feb2021. By 2 pm the same day he experienced joint pain, sweating, & nausea. Caller requesting a telephone number to contact HR. Caller would like to know why they are violating clients (federal law name) rights as per his wife's OBGYN/Paediatrician. His wife went for her Pfizer BioNTech Covid vaccine and was denied the vaccine due to breastfeeding. Wife was advised to get permission slip from her HCP. Wife has spoken with Paediatrician/OBGYN who both advised that it was against (federal law name) to provide a letter. Caller asking why should she need a letter to receive the vaccine. The outcome of the events was unknown.   No follow up attempts are possible: information about lot/batch number cannot be requested.
At time of shot arm was sore. Each day became progressively worse. Tried heat but made worse. Tried NSAIDS, not helping. Ice helped for short periods. Nearly 3 months later still sore. Range of motion is limited.
I'm not sure this is a result of the Shingrix vaccine, but about one month after my first Shingrix shot, I suddenly developed numbness, tingling and burning in my hands, which then spread to my arms (up to elbow) and my feet (up to my lower calf), and on both sides of my body. I was diagnosed with Idiopathic Peripheral Neuropathy. I told every medical professional I consulted with during this time, that the onset of the neuropathy occurred about one month after my first Shingrix shot. I didn't know I could report it until just now, so I am doing so just in case others have reported a similar issue.
Patient called pharmacy on 10/17/17 and said she got a flu shot on 10/16/2017 and that she developed a bad headache. She said she thought it was related to flu vaccine. She said she had taken different otc headache medicine and they had not helped. Also she said she had history of high blood pressure and had not taken her medication. I told her to go to the doctor to get checked out .
Three month old infant received DTaP, HIB, IPV, PCV and HEP B without incident at that time. At 1:30pm, the same afternoon mom called the clinic to state that infant had an odd cry and her eyes were rolling to the back. Clinic nurse instructed the mom to take to ER. Er nurse stated no further orders were needed. No adverse findings present.
This is a spontaneous report from a contactable consumer. A 18-year-old male patient received on 12Jan2017 TRUMENBA at 0.5 ml single dose and human papilloma vaccine (HPV) at 1 DF single, both for immunization. Medical history and concomitant medications were not reported. On 13Jan2017, the patient experienced fever, chest was hurting, headache, not feeling good at all and stomach did not feel good. Outcome was not recovered.
Feeling bad; My brain feels like it's going totally different way; Nauseous; Headache/sometimes during my headache I have my head hurts; Tired all the time; I am not well; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 29Apr2021 (Thursday) as second dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. The patient was feeling bad since 29Apr2021 (late Thursday) evening and was just curious to know how long that these symptoms can go on because the patient had to go back to work the next day (30Apr2021). The patient was feeling a little nauseous and had a headache while sometimes during headache, the head hurts on an unspecified date in 2021. The patient was tired all the time and the brain feels like it's going totally different way on an unspecified date in 2021. The outcome of these events was unknown at the reporting time.
Was worried that she will not develop antibodies; Vaccinator gave it to her under the skin and not in her muscle; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Was worried that she will not develop antibodies) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccinator gave it to her under the skin and not in her muscle) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intradermal) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccinator gave it to her under the skin and not in her muscle). On an unknown date, the patient experienced ANXIETY (Was worried that she will not develop antibodies). On 16-Sep-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccinator gave it to her under the skin and not in her muscle) had resolved. At the time of the report, ANXIETY (Was worried that she will not develop antibodies) outcome was unknown.            No Concomitant medication were reported. No Treatment medications were reported.  The patient got second dose on 16-Sep-2021, however, the patient did not felt any injection at all. The patient had no soreness in arm, not even a tiny bit, not even anything that looks like a needle had been there, no bruising. The patient was positive the vaccinator gave it under the skin and not in muscle. The patient was worried that antibodies would not be developed.  The patient states that her HCP is new, and had an appointment coming up on 28-Sep-2021.   This case was linked to MOD-2021-322930 (Patient Link).
UNEXPLAINED HEADACHES; PROBLEMS IN BREATHING; PAIN IN LOWER EXTREMITIES; This spontaneous report received from a patient concerned a female of unspecified age. 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) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced problems in breathing. On MAR-2021, the patient experienced pain in lower extremities. On an unspecified date, the patient experienced unexplained headaches. Laboratory data (dates unspecified) included: Scan (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from problems in breathing, and pain in lower extremities, and had not recovered from unexplained headaches. This report was non-serious.
Subsequently post vax, the pt developed an area of redness at the injection site, measuring 5 cm. The pt recovered.
had an outbreak of Herpes; This spontaneous case was reported by a consumer and describes the occurrence of HERPES VIRUS INFECTION (had an outbreak of Herpes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Herpes infection.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced HERPES VIRUS INFECTION (had an outbreak of Herpes). At the time of the report, HERPES VIRUS INFECTION (had an outbreak of Herpes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient had outbreak of Herpes approximately two weeks after the first dose. Treatment information was not provided.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included that the patient had two heart attacks, and concurrent conditions included: cancer, and rheumatoid arthritis, and other pre-existing medical conditions included that the patient had no known drug allergies and was suffering from multiple ailments. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1082068 expiry: Unknown) dose was not reported, 1 total administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The patient was not pregnant at the time of reporting. On 11-AUG-2021, the patient visited her Infectious Disease doctor who carried out the COVID (Corona virus) antibody test which came out to be negative (confirmed immunological vaccine failure). The patient never had COVID. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210842984-COVID-19 VACCINE AD26.COV2.S-confirmed immunological vaccine failure. This event(s) is considered not related. 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
This spontaneous report was received from an office manager concerning to multiple patients of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medication, were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (Lot# and expiration date were unknown) for prophylaxis, which had a temperature excursion 27°F for 10 minutes and 28°F for 14 hours. No previous temperature excursion were reported. The reporter stated that the temperature excursion was detected by a data logger. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA009059: US-009507513-1702USA009057: US-009507513-1702USA009058.
96.5 kg 54 yo F with NKDA was administered Tdap, influenza and pneumococcal vaccines on 10/31. Flu 0.5ml to left deltoid manufacturer SKB lot AFLUA715AA; Pneumovax 23 0.5ml right deltoid manufacturer MSD lot H013581; TDap left deltoid 0.5ml manufacturer SKB lot AC52B094CA. On 11/1/12, pt reported being unable to raise her arm due to muscle pain. Area not erythematous or warm to touch. Pt had temp of 99.4 oral.  Unreported but this appears to be first vaccination with Pneumovax.
From telephone correspondence received on 11/1/02, it was reported that an adult female received Fluzone on 10/25/02., Approximately 2 to 3 days post vaccination, she began to experience sensations of muscle twitching, which the patient described as a numbness and tingling of the upper and lower extremities. Per the physician, the patient was experiencing paresthesias and restlessness. She has a history of psychiatric episodes and was seen by the physician to get her influenza vaccine. On 10/31/02, the patient was seen by her psychiatrist, who noted marked facial dyskinesia. The patient is currently taking several psychiatric medications for bi-polar disorder. Reportedly, the symptoms are still persisting, although the patient states they are starting to improve. From additional information received on 4/3/03 from the reporting physician, it was reported that the patient was 39 year old at the time of the administration of Fluzone, lot number is U0904CA and was given IM in her deltoid. Reportedly, the patient was seen by the physician on 10/29/02 and recovered from the adverse reactions. No further information is anticipated, this case is closed.
Vaccine provided 5/11/16. Symptoms of redness, warmth, swelling (central wheal) at site began on 5/17/16.
Moderna COVID-19 Vaccine EUA 02/24 1700 Vomited 02/24  0000 Sore arm, applied ice pack 02/25 0430 Vomited 02/25 Morning and Mid-Day nausea.  General feeling of unwell.
Subject in pneumococcal vaccine trial, with severe COPD hospitalized for COPD Exacerbation. Vaccination took place on 10/13/08. According to physician the relationship is 'None'.
This is a spontaneous report from a RN referring to a 50 year old male who received the 1st dose of Lymerix on 7/22/99 and 2nd dose on 8/26/99. Two days after receiving 2nd dose, the pt experienced flu-like symptoms, aching joints, fever, fatigue and nausea. The most recent information, received on 8/30/99, reports the condition of the pt is ongoing.
On the same day of the vaccine I experienced pain on my left arm felt heavy. The symptoms lasted for three days.
Patient woke up with a pain in his left eye and then a little while later he couldn't see anymore. He went to an optometrist who told him he possibly has herpes zoster in his eye and gave him some eye medications. He will follow up with an ophthalmologist.
child developed hives and facial swelling w/in 5 minutes after receiving Fluzone and Varivax vaccines. Subsequently, developed wheezing and decreasing blood pressure. Rx'd with SC Epinephrine x 3 doses, took Benadryl and steroids
patient lost consciousness twice, lost all his color, and it was reported that he was tremoring as if having a seizure
Initial information received on 05-Apr-2019 regarding an unsolicited non-valid non-serious case received from a nurse. This case involves a 15 years and 9 months old patient who was vaccinated with MENACTRA and TRUMENBA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 18-Jul-2014, the patient received a MENACTRA (Solution for injection) (lot: U6207AA, expiry date: 25-May-2020) in the left arm. On an unknown date, the patient received a dose of suspect TRUMENBA not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. It was an actual medication error due to Inappropriate schedule of vaccine administered. It was reported that the patient had a dose of MENACTRA on 18-Jul-2014 so it hasn't been five years and received TRUMENBA. It was unknown whether the patient had any adverse event. 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. List of documents held by sender: none.
Got 2nd dose on 5/18/ Called office on 5/28 reporting red, itchy rash. Advised to apply hydrocortisone + cool compress and to call if worsens. Called on 12/21 reporting "bruise" from covid shot worsening. Appointment made. Per Dr it started as circumferentially and is now raised scabbing. No drainage or erythema. Has left shoulder tenderness. Dr questioning possible keloid like reaction. Recommended seeing dermatology
warm, reddened, hardened area-cellulitis appearance;softball size still sore on 20NOV98;
This spontaneous report as received from a pharmacist refers to a male patient of unknown age with drug reaction/allergies to ZITHROMAX. Medical history and concurrent conditions were not reported. On 15-SEP-2013, the patient was vaccinated with a first dose of GARDASIL intramuscular, for the indication "recommended". Dose and lot number were not reported. No co-suspect therapies were reported. Concomitant therapies included FLONASE. The pharmacist stated that after the patient received the first dose of GARDASIL, he fainted "right away". The pharmacist stated the patient was "fine after a little while". The patient had the second dose of GARDASIL (lot #, dose and expiration date not reported) intramuscular, "a week after 14-NOV-2013", approximately on 21-NOV-2013, and then developed hives all over his body. The pharmacist stated that the patient's father is a physician, who prescribed prednisone (manufacturer unknown) for the reaction on an unspecified date. The pharmacist stated the patient would discontinue the GARDASIL series and would not receive the third dose "based on his father's recommendation and his reaction to the vaccine". The pharmacist stated that patient's hives are still present. The therapy was discontinued. The adverse event did not improve. The patient sought medical attention. Additional information has been requested.
diarrhea; changed in bowel activity; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and FUNCTIONAL GASTROINTESTINAL DISORDER (changed in bowel activity) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DIARRHOEA (diarrhea) and FUNCTIONAL GASTROINTESTINAL DISORDER (changed in bowel activity). At the time of the report, DIARRHOEA (diarrhea) and FUNCTIONAL GASTROINTESTINAL DISORDER (changed in bowel activity) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Confusion, difficulty walking, muscle soreness in places other than injection site, amxiety attack lasting for more than 6 hours.
Red bump rash all over chest and back within hours. Consequently the rash has now spread all over the body including the face. The bumps are slightly elevated and there is not itch or pain.
Information has been received from a nurse referring to multiple unspecified patients. Their medical history, concurrent condition and concomitant therapy were not provided. On an unknown date, the patients were administered improperly stored PROQUAD (strength, dose, frequency and route were unknown; lot number and expiration were L051098/17-JUN-2017, M006102/01-AUG-2017. No adverse effects reported. The temperature excursion was 6.8 degree Fahrenheit for 45 minutes. There was no previous temperature excursion. This report was for data logger. This is one of several reports received from the same reporter. Additional information has been requested.
UNCONTROLLABLE SHAKING; SORE ARM; CHILLS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included headache.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-APR-2021 13:05 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included acetylsalicylic acid/caffeine/paracetamol/salicylamide for headache. On 01-APR-2021, around 23:00 the subject experienced uncontrollable shaking. On 01-APR-2021, the subject experienced sore arm. On 01-APR-2021, around 23:00 the subject experienced chills. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm, chills and uncontrollable shaking was not reported. This report was non-serious.