chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diarrhea; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, on 03Mar2021 as a SINGLE DOSE for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included ibuprofen (ADVIL) taken for an unspecified indication, start and stop dates were not reported. Patient reported that received the COVID-19 vaccination on Wednesday 03Mar2021. Saturday evening and Sunday (on06Mar2021 and 07Mar2021) had diarrhoea. It was reported that while there was a stomach bug passing around patient's family the prior week, patient was unsure if had the same bug or if it was from the vaccine, so reporting out of an abundance of caution. The outcome of the event was reported as unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
This spontaneous report as received from a registered nurse via a company representative concerning a female patient two patients were also reported of unknown age who on an unknown date started therapy with [therapy unspecified] (THERAPY UNSPECIFIED) (dose, duration and indication were not reported). The registered nurse stated that on an unknown date the patient had 0 titres. It was reported that was unsure what products or vaccines the patients had received prior to the low titres count. Action taken with suspect therapy was unknown. The outcome of patient had 0 titres was unknown. Follow-up received. This report concerns a 21-year-old female patient. She was vaccinated with a dose of Hepatitis B Vaccine (Recombinant) (manufacturer unknown). Patient had no antibodies to Hepatitis B. This patient was being revaccinated with the Hepatitis B vaccine (Recombinant) (manufacturer unknown). No patient names were provided. This is one of the several reports from the same source. Additional information has been requested.
I was very sick from the 1st shot had to miss work for 2 days. Nauseous, extreme pain all over.  2nd shot I was sick for a whole week and missed work because of it. Nauseous and even more extreme pain than the first shot. Could barely move and couldn't sleep because of the pain. Adverse events started right away but didn't get diagnosed until March 2022 for Hypothyroidism, now on levothyroxine for that. No energy, couldn't focus, no feeling (emotions) at all. Later 2022 was diagnosed with fatty liver disease and cervical radioculapthy. Have changed lifestyle and eating habits to help with fatty liver disease. Chiropractor for musculoskeletal issues. Symptoms for fatty liver chronic diarrhea that was green and watery or very mushy. Chronic abdominal pain, nausea, my skin feels like it's on fire and like glass in my hands. Severe neck pain so I bought a new pillow and try to stretch it out every day. Chiro helps with pain management. The new diet has helped some with the abdominal pain and I've lost 17 lbs. Still have to watch what I eat and I cut out Mt dew and anything with high fructose corn syrup. I also am using stevia instead of sugar for a sweetener. More raw protein like eggs, bacon, steak, and less carbohydrates.
Client received flu vaccine at 400PM on 12/6/07.  She awoke at 200AM with shaking chills and total body aches.  At 400AM she awoke drenched in sweat, states this lasted until 600AM.  When she called heath department she c/o soreness.  Client phoned CDC and was informed to call the VAERS line which did not answer.  Called health department at 1035AM.
1 week after my first dose, I noticed I was very itchy, red and swollen (hard) at the injection site. I put Benadryl cream on it and the itching immediately stopped but swelling and redness took about one day to reside. I noticed left pec chest, armpit, and deltoid pain for about 2 weeks after shot also.
Renal failure; Horrible Headaches; Body ache; A spontaneous report  was received from a consumer concerning an 83-year-old male patient, who was administered Moderna's COVID-19 vaccine and one week later, he had horrible headaches, body ache and hospitalized for kidney problem (Renal failure).  The patient's medical history included diabetes and high blood pressure. Products known to have been used by patient, with in two weeks prior to the event, included apixaban, sitagliptin, carvedilol, furosemide, glipizide.  Patient became COVID positive on 14-DEC-2020 while in the hospital and survived.  On 02-Feb-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 09-Feb-2021, approximately one week later, patient had horrible headache and body ache. Patient is better now but he is in the hospital because he has kidney problems (Renal failure) started on 14-Feb-2021. Patient's wife mentioned in call that this has never happened in past and she already asked MD not to give him the second dose. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was discontinued.  The outcome of the events, he had horrible headaches, body ache, were considered resolved. The outcome of the event hospitalized for kidney problem (Renal failure) was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Patient's elderly age and medical history of diabetes and high blood pressure may have been contributory for the event of renal failure.
2 days later, a mother called and stated her daughters arm (left arm) was swollen considerably down to her fingers. The mother was encouraged to put ice on the arm and take her to the family doctor. The doctor saw the child and confirmed reaction and placed her on Clariton.
A non-serious spontaneous report of a we gave expired H1N1 to several patients was received from a registered nurse/health professional concerning a 30-year-old female out of 17 patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine expired on 15-Jan-2010. The original expiration date 12-Feb-2010, had been changed to 15-Jan-2010. On 20-Jan-2010, the patient received H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered recovered.
This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 70-year-old female patient who received SHINGRIX (batch number ML532, expiry date 13th July 2020) for prophylaxis. On 16th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 17th May 2018, 1 days after receiving SHINGRIX, the patient experienced blister. On an unknown date, the patient experienced rash. On an unknown date, the outcome of the blister was unchanged and the outcome of the rash was not recovered/not resolved. It was unknown if the reporter considered the blister and rash to be related to SHINGRIX. Additional information was reported as follows: The patient received SHINGRIX on the left arm. The next day after receiving SHINGRIX, the patient had water filled blisters on her belly, she did not think it was shingles. The rash came and went but was not resolved till the date of reporting.
4cm circular swelling L thigh. Increased warmth. No significant pain, no limp.
have others reported skin rashes with Moderna?; This spontaneous case was reported by a consumer and describes the occurrence of RASH (have others reported skin rashes with Moderna?) 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) 1 dosage form. On an unknown date, the patient experienced RASH (have others reported skin rashes with Moderna?). At the time of the report, RASH (have others reported skin rashes with Moderna?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided
9-24-09 10:30 Telephone call-spoke with mother-she reports son presented this AM with a mild fever, 99.6 degrees, flushed face, sneezing, sore throat and cough. She gave him MOTRIN-better now-questioning if this illness is from the vaccines he received on 9-15-09-no local reaction to arms-had 1 pox on LD from VARIVAX.
PATIENT ATTESTED ON HER VACCINE INTAKE FORM THAT SHE HAD NEVER RECEIVED A COVID19 VACCINE. WE GAVE THE VACCINE AS REQUESTED. UPON ENTERING THE VACCINE IN OUR PHARMACY SOFTWARE, WE SAW THAT SHE HAD RECEIVED A 2 DOSE SERIES OF MODERNA VACCINE AT ANOTHER LOCATION WITHIN OUR COMPANY IN DECEMBER 2020 - JANUARY 2021.
Information has been received from a physician concerning a 14 month old female with no drug allergies or reactions a history of reactive airways and frequent rhinitis who on 17-OCT-2008 was vaccinated with the first dose of VARIVAX (Merck). Concomitant therapy included MMR II (dose not reported). Other concomitant medication on that same date included Influenza virus vaccine (manufacturer unspecified). On 18-OCT-2008 the patient developed a low-grade fever, one day after receiving her first dose of MMR II and VARIVAX (Merck) on 17-OCT-2008. On 22-OCT-2008 the patient developed a high fever, vomiting, muscle twitches and a febrile seizure. On 22-OCT-2008 the patient was seen in the office that day, a complete blood count, urinalysis, sed rate, C-reactive protein and chest x-ray were negative. On 24-OCT-2008, the patient's mother sought a second-opinion in a local emergency room. The physician relays a "completed workup" of unspecified tests in the emergency room were negative. On 25-OCT-2008, the patient became afebrile. On 30-Oct-2008 the patient was seen in the office again because of a decrease in hand-eye coordination and episodes of "vacant staring". It is not known if these episodes are seizure. The physician is ordering an electroencephalogram and, possibly, a neurological consult. On 30-OCT-2008 the physician reported that patient was not recovered from febrile seizure, decrease in hand-eye coordination, muscle twitches, vacant staring and vomiting. No further information is available. Upon internal review febrile seizure was considered as an other important medical events. Additional information has been requested.
Lymph nodes in the right armpit have swollen to golf balled sized lump which is hard and painful. A few lesser swollen lymph nodes in the right side of the neck. Headache, sore muscles, and fatigue also.
Patient received first dose of Covid vaccine and was given Pfizer, today was due for 2nd dose and given Moderna.
8/17/13 poor feeding, uncomfortable, fussy (+) blood in stool vomited x1. He was referred to hospital, he was diagnosed and treated for intussusception.
Local reaction on right arm. Hot, red, hard, sore to touch. Headache, fatigue, three days later
Patient received injection 6-9-08. Exposed to family with in last 1 month with severe chicken pox. Patient in our ED with other concerns. Presumed chicken pox, identified based on patient assessment. Unsure if related to vaccine history. Patient is immucompromised.
Initial after first dose: dizziness, tingling, low BP, low glucose, chest pain  In the weeks following dose: BP spikes, chest pain, weakness, tingling, tiredness
second  full term  periods with heavy bleeding  and severe  cramps plus two days on the roll  diarrhea  I had my  regular periods started on  August 27/21 and the  other  periods  on September 8/21.  I never had any abnormality and irregularity  in the past .  I had vaccine shot on  September 5/21
Pt got 1st Anthrax at 14:45 L deltoid on 1/6/03 on 1/8 about 23:00 developed a really severe headache, next day, same headache, used OTC meds. Left for deployment but headache cont'd and lasted until the 19th. Hives, chills started on 1/13, was unable to work. No fever. By now, much less headache, hives are gone.
RECEIVED JANSSEN VACCINE TODAY. DURING POST ADMINISTRATION DOCUMENTATION, DETERMINED THAT PATIENT HAD PREVIOUSLY BEEN VACCINATED WITH MODERNA VACCINE- 2 DOSES, LAST IN 4/2021
Presented to ED 3/8/10, seen @ dermatology clinic 3/9/10 started on prednisone taper, triamcinolone cream, hydroxyzine, referral to nephrologist, cardiologist and dietician diagnosis of Henoch - Schonlein purpura.
Myocarditis; The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on 18Jun2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable consumer (Patient).  A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6200) via an unspecified route of administration on an unspecified date as 2nd dose, single for COVID-19 immunization. No medical history and concomitant medications were reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9269) via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization and had abnormal side effects. On an unspecified date the patient experienced myocarditis. She mentioned that she was 76-year-old woman not a teenager or 30-year-old man. She stated that she had to run around and spend like 20minutes going through all these menus and was not helpful. Patient doctor wants to call and report that they think patient have Myocarditis. Patient wanted to connect to the medical department so that she can talk to the nurse to know if her problem was the result of the vaccine. The outcome of the event myocarditis is unknown.  Information on Lot/Batch number was available. Additional information has been requested.
onset of cough, runny eyes, headache, inside of mouth hurt, difficulty breathing, ache all over. Went to ED at 4:30pm felt reaction to vaccination. Patient took Benadryl at home after the ED visit.
This spontaneous report as received from a health care worker refers to a patient of unknown age and gender with no pertinent medical history/drug allergies or drug reactions reported. On an unspecified date in 2014, "approximately one year ago" the patient was vaccinated with the first dose of GARDASIL (route, anatomical location, lot# and expiration date were not reported). On 20-MAY-2015, the patient was vaccinated with the second dose of GARDASIL (anatomical location, lot# and expiration date were not reported), intramuscular. There was no concomitant therapy reported. No adverse event was reported. Additional information is not expected because the reporter did not provided the physician's contact and stated that they do not want any further contact regarding this case.
Call from client today.  States within 6-12 hours of getting his Moderna Booster at 1:30 on 11/28/22 he developed high fever (he never measured his fever), severe chills to the point of spasms and nausea for 3 days.   Symptoms were controlled with Ibuprofen, he called his doctor but was not seen, no hospitalization.  He was insistant that a report be filed.  I recommended he get tested for flu or covid but he declined.  Stated he knew his body and it was a reaction to the vaccine.  It was his 5th covid vaccine, only moderate side effects with first dose.
This case was reported by a healthcare professional (nurse) and described the occurrence of expired vaccine used in a 27-month-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). On 13 February 2014 the subject received a dose of HAVRIX (.5 ml, unknown details) and experienced expired vaccine used. The nurse reported that the subject "inadvertently received an expired HAVRIX." The expiry for HAVRIX was 10 February 2014.
3DEC93 felt badly, h/a, lumps @ back of neck, n/v, muscle aches, pains, coughing, sneezing, hot & cold; 6DEC93 enlarged lymph nodes @ base w/hairline per MD:
Wakened early am by itching in right upper arm, between elbow and site of injection.  skin somewhat mottley, without hives, bumps, or blisters.  No systemic or generalized symptoms.  Mother may administer oral allergy med, but does not plan to seek medical attention at this time.
This spontaneous report was received from a healthcare professional referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. On 17-NOV-2015, the patient was vaccinated with PNEUMOVAX 23, (dose, lot # and expiration date were not provided). Concomitant medication was not reported. On 18-NOV-2015, reported as "within 24 hours", the patient experienced terrible pain in the arm after being vaccinated with PNEUMOVAX 23. The outcome of pain in extremity was reported as recovered on an unspecified date in November 2015, reported as "approximately one week after vaccination". The reporter did not assess the relatedness between pain in extremity and PNEUMOVAX 23. This is one of the several reports received from the same source. Additional information has been requested.
Sore Mouth; This is a spontaneous report from a contactable Nurse. An 86-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021 (last week) at SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sore mouth on Jan2021 (reported as yesterday).  The outcome was recovered on Jan2021.  Information on the lot/batch number has been requested.
I developed shingles on and about Jan 18 on the right side of my back. I saw the dermatologist on the 19th, I think. I was placed on a Medrol dose pack and took Acyclovir - 150 -200 mg  - it took about two weeks to resolved.  I had had shingles before. Same side of my body and same dermatomes - about 5 five years ago.
Fever to 101F Chills Aches Headache 1 episode vomit
Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 72 years old female patient who experienced severe pain- in her left arm and could not lift it, while she received vaccine FLUBLOK TIV. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 08-Oct-2018, the patient received a dose of suspect INFLUENZA TRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, patient developed a non-serious severe pain- in her left arm and could not lift it  following the administration of INFLUENZA TRIVALENT RECOMBINANT VACCINE. Lab data was not reported. Final diagnosis was severe pain- in her left arm and could not lift it. It was not reported if the patient received a corrective treatment. The patient was not recovered from event. (The event was ongoing at the time of reporting). Additional information was received on 18-Oct-2018 from a consumer. No new information received. List of documents held by sender: none.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Mild
Patient filled out consent and release form for Moderna Covid-19 vaccine for her 1st dose but was given Janssen Covid-19 vaccine instead.
Vx don´t work, know from experience/suspected vaccination failure; Vx don´t work, know from experience; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that the vaccine did not work and reported he/she knew from experience. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding primary schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
9cm X 9.5cm area of erythema with a 4cm X 5cm area of slight induration in the center. Area is mildly warm and tender.
Bells palsy; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (Bells palsy) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037k20A and 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included VITAMIN 15 for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced CHILLS (Chills). On 08-Feb-2021, the patient experienced FACIAL PARALYSIS (Bells palsy) (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS (Bells palsy) had not resolved and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.   This case was linked. Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
I have not seen a doctor yet. Just to be clear, I do occasionally get head aches but they've been noticeably worse and more frequent since the day after the second dose, though not nearly as bad as that day. I developed a persistent cough on the 2nd day after the 2nd dose and it's been getting a little worse every day since (this is currently the end of day 5). It's not so bad yet that I can't control it so I can resist coughing when I'm at work usually but this definitely doesn't feel normal. Last night, after a particularly bad bout of coughing I got a few very strange, burning body aches on my neck, shoulders, and stomach but they went away after a few minutes. I've had coughs before but not that.
severe headache; viral type symptoms; This is a spontaneous report from a contactable other HCP via Pfizer sales representative.   A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA) at single dose on an unspecified date for immunisation.  The patient medical history and concomitant medications were not reported.  Four-five days after receiving the vaccine, the patient went back into the office with severe headache and viral type symptoms on an unspecified date. The outcome of events was unknown. The reporter was not sure if it was a viral infection or if symptoms resulted from Trumenba.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.