chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt dizzy; Possible rash on face 2 days after dose but thought was acne due yo wearing mask at work; naseous around noon; hives; Rash/Rash on chest and torso, both arms and both legs/Possible rash on face 2 days after dose but thought was acne due yo wearing mask at work; This is a spontaneous report from a contactable consumer (patient) reported for himself.  A 52-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 17Apr2021 at 10:00 am (Batch/Lot Number: ER8737) (age at vaccination 52-year-old) as dose 1, single for covid-19 immunisation at Hospital. Medical history included recent high cholesterol diagnosis about 3 weeks ago started meds, known allergies: triple anibiotic ointment, sulfa meds from an unknown date and unknown if ongoing. The patient had known allergies with past drugs included amoxicillin, doxycycline, augmentin bambini, zithromax. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received other medications included rosuvastatin, cetirizine hydrochloride (Zyrtec) and paracetamol (Tylenol) within 2 weeks of vaccination for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. After 3 days of dose 1, the patient experienced felt dizzy, naseous around, about 4 hours later hives, rash/rash on chest and torso, both arms and both legs/possible rash on face 2 days after dose but thought was acne due yo wearing mask at work and possible rash on face 2 days after dose but thought was acne due yo wearing mask at work on 20Apr2021 at 16:00. Took Zyrtec 10 mg about 4pm. Therapeutic measures included antihistamine was taken for all the events. The outcome of the events was not resolved.  No follow-up attempts are possible; No further information is expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 05-MAR-2013, the patient was inoculated with ZOSTAVAX by the physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 24-MAY-2016, the patient was treated by the physician for the onset of a vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the 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 and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
GAS; NAUSEA; HEADACHE; ABDOMINAL ACHE/ DISCOMFORT; ADMINISTRATION OF VIVOTIF DOSE WITH LIQUID KEFIR; This spontaneous case report (PVX2019-1576) was received from a consumer on 18-Jun-2019. It describes a 73-year-old elderly female consumer who had nausea, headache, abdominal ache/ discomfort, and gas, after the "administration of Vivotif with liquid kefir" (one capsule every other day orally) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif with liquid kefir on 17-Jun-2019. On the same day, she developed nausea, headache, and abdominal ache. The symptoms worsened during the day. Later, she had a lot of gas.   She took two doses of oral Gas-X (simethicone), one in the late afternoon and another in the evening. She also took one dose of Pepto (bismuth subsalicylate) in the evening for the treatment of side effects on 17-Jun-2019.  She had gluten sensitivity for the past 10 years.  She did not take any concomitant medication.  Action taken with Vivotif with respect to the events nausea, headache, abdominal ache/ discomfort, and gas was unknown while with respect to the event "administration of Vivotif dose with liquid kefir" was not applicable.  The consumer had been recovering from the events nausea, headache, and abdominal ache/ discomfort, while with the event gas was recovered, and the clinical outcome of the event "administration of Vivotif dose with liquid kefir" was unknown.  Company's Comment: In this case, it was reported that the consumer had nausea, headache, abdominal ache/ discomfort, and gas, after the "administration of Vivotif with liquid kefir". There seems to be a temporal association between the intake of the vaccine and the events. Also, nausea, headache, abdominal ache/ discomfort, and gas are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event "administration of Vivotif dose with liquid kefir" was considered as not applicable.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had nausea, headache, abdominal ache/ discomfort, and gas, after the "administration of Vivotif with liquid kefir". There seems to be a temporal association between the intake of the vaccine and the events. Also, nausea, headache, abdominal ache/ discomfort, and gas are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. The causality of the event "administration of Vivotif dose with liquid kefir" was considered as not applicable.
Anthrax-immunized area swollen, redness painful, itching, and unable to move arm
suspected transmission of an infectious agent via product; abnormal pap tests; vaccination failure; cervical dysplasia; contamination; cervical cancer; cervix carcinoma in situ; cervix carcinoma stage I; cervix carcinoma stage III; high rates of autoimmune disorder; This non-valid spontaneous report was received from physicians in a form of video via social media via vendor and refers to multiple female patients of unknown age.   On an unknown dates, the patients were vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection for prophylaxis.         It was reported in a video that the pathologist was initially contracted to examine a single sample of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) for possible contamination. The sample (lot # was not specified) was tested positive for recombinant HPV-11 and HPV-18 residues both of which were firmly attached to aluminum adjuvant. It was also reported that high rates of autoimmune disorders, 380 reports of abnormal pap smears, 137 reports of cervical dysplasia, and 41 reports of cervical cancer including carcinoma in situ, cervix carcinoma or cervix carcinoma stage 0 or cervix carcinoma stage I or cervix carcinoma stage III warranted an immediate investigation of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) safety and efficacy.  Outcome of the events and the causality assessment were not specified.  Upon internal review, the events of autoimmune disorder, cervical cancer and suspected transmission of an infectious agent via product were considered to be medically significant.  This case is considered non-valid due to hearsay/ second hand information.
Aches, chills, feverish, yawning, malaise - no treatment except ibuprofen and time.
Vaccine was administered to patient. Injection site reaction of increased bleeding and swelling about the size of a quarter at location of injection. Subsequently went down over 24 hrs per patient.
Body Weakness, bone and muscle pain, numbness and tingling of legs, unable to move legs, dizziness,  fatigue, nausea and dry retching. Full body skin burning, fever, chills
This spontaneous medically confirmed report (initial receipt 28-Aug-2015) concerns a 32 year old female patient. The patient had no medical history. On 28-Aug-2015, the patient inadvertently received an intramuscular dose of expired AFLURIA (batch number 10249211A, expiry date: 30-Jun-2015) at 0.5 ml once. No adverse reaction occurred since administration. The outcome was reported as recovered. Reporter's comments: The reporter assessed the event as non-serious. Follow-up (08-Sep-2015): The spelling of the reporter's name updated. No new information.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's concurrent conditions, concomitant therapies or medical history was reported. On 05-OCT-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot# M001745 with an expiration date 07-APR-2016 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 20 degrees Fahrenheit for 13 hours and then 20 degrees Fahrenheit for 6 hours. Data logger was not involved. The patient had not experienced an adverse effect. Additional information has been requested.
This spontaneous report was received from a consumer, referring to himself, a 60 and a half year old male patient. The patient's medical history included celiac disease. Concurrent conditions were not reported. On an unspecified date in February 2015, the patient was vaccinated with one dose of ZOSTAVAX (lot number, expiration date, dose and route of administration were not reported) in the left arm for prevent shingles. Concomitant medication was not reported. The patient stated that, on an unspecified date in 2015, about 2 weeks after he got the ZOSTAVAX vaccine, he developed itchy, half inch, hives. He stated they are primarily on his face, but also on neck, chest, and arms. the patient sought medical attention and was treated with steroids. The outcome and causality of the hives were unknown. There were product quality complaints reported. Additional information has been requested.
PT got shot was with mom, seemed ok. Sat down to wait  the 15 minutes, at about 7 minutes after sitting fainted.
bloody stools; diarrhea; This case was reported by a nurse via sales rep and described the occurrence of blood in stool in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 3CR3S, expiry date 12th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 1st March 2021, the patient received the 2nd dose of Rotarix lyophilized formulation (oral) 1 ml and Rotarix Oral Applicator Device. In March 2021, less than a week after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced blood in stool (serious criteria GSK medically significant) and diarrhea. On an unknown date, the outcome of the blood in stool and diarrhea were not recovered/not resolved.   It was unknown if the reporter considered the blood in stool and diarrhea to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Two days after receiving Rotarix vaccine the patient mother came into the office complaining of bloody stools, diarrhea. Stool cultures were ordered and was pending. The reporter reported that there are no new events. The reporter consented to follow up. This case was 1 of the 3 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR058802:same reporter US-GLAXOSMITHKLINE-US2021AMR058850:same reporter
muscle weakness, sweating, weak, loss of appetite, bone pain, muscle pain, fingers tingling. hands hurting, left leg heaviness.
Covid; Covid; This is a spontaneous report received from a contactable reporter (other healthcare professional, HCP).  An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid".  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 in this patient cannot be completely excluded.
Patient felt dizzy and fainted in moms lap in the observation area approximately 10-15 minutes post vaccination. States she felt lightheaded, diaphoretic and started seeing spots. Patient was out for a few seconds and was able to sit back up and take fluids. VS taken, BP 110/70 manual, HR 62 radial (40s initially on the digital pulse ox) , oxygen 98%, RR 18. Approx. Fluids and additional observation for 30 minutes. Patient improved and was able to ambulate to the car safely accompanied by myself and observation RN. Advised patient and mom to continue to rest, take plenty of fluids, and if symptoms return to go to urgent care or ER. Patient and mom verbalized understanding.
client experienced lightheadedness and visual changes in which everything appeared yellow within 5 minutes of the injection. vital signs remained stable w/o resp distress. Denied any dizziness or nausea. Client observed on unit for 40 minutes w/o any worsening changes. Client left unit w/o apparent distress with improvement in vision.
patient said 4 to 5 days after his 2nd vaccine he had a rash that progressed. He went to the Doctor and they put him on prednisone.   The rash is better now.
Headache; Chest pain; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: ER2613), dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot Number: ER2613) as dose 1, single for covid-19 immunisation (at the age of 63-year-old). Medical history included High blood pressure from an unknown date and unknown if ongoing. Concomitant medications included paracetamol (TYLENOL) 500mg, felodipine (FELODIPINE) 5 mg, once a day, Vitamins taken for an unspecified indication, start and stop date were not reported. The patient experienced headache, Chest pain. Consumer stated, I have been having side effects from the Pfizer shot that I got. Consumer stated, I took some Aleve one day and then I took some Tylenol. Tylenol don't agree with me, so I have not taken down no more of, so that's about its Aleve and Tylenol, or I can say I have taken that one day (voice feeble). The Tylenol that I took it was 500 mg. The Aleve, they are 220 mg. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
FEVER; CHILLS; FATIGUE; VERY BAD HEADACHE; This spontaneous report received from a patient concerned a 19 year old female. The patient's weight was not reported and height was 67 inches. The patient's concurrent conditions included non alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced very bad headache. On 13-APR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 12-APR-2021, and had not recovered from fatigue, very bad headache, and fever. This report was non-serious.
Developed episodes of tachycardia and desaturation, with any normal exertion, debilitating in the months following COVID vaccines.  It took almost a year of testing (ekg, echo, labs, steroids, antibiotics, holter monitor, long walk test, PFT?s, finally Pulmonary CT scan w/contrast). ). Difficult to get in person MD appointments at that time. Finally referred to Pulmonologist. CT scan revealed innumerable pulmonary nodules with diffusion issues. Repeat CT scan unchanged. NO other explanation for this now chronic disease issue from lung lining damage.
soreness in her arm /sore around the injection site, pain; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported for an 84-year-old female patient that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3248), via an unspecified route of administration at arm on 21Jan2021 13:00 at single dose for COVID-19 immunization. The patient medical history was not reported.  There were no concomitant medications.  The patient experienced soreness in her arm /sore around the injection site, pain on 21Jan2021 with outcome of unknown.
Had to remove my mask, felt like it was suffocating me (normally no issues with a mask); Broke into heavy sweat, soaked my clothing.; Felt disorientated, could not get up from chair.; This is a spontaneous report from a contactable consumer. This consumer reported for herself that the 47-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, Pfizer) at the age of 47-year-old, dose 2 via an unspecified route of administration, administered in Arm Left on 16Jul2021 13:00 (Batch/Lot Number: EW0181) as dose 2, single for covid-19 immunisation. Medical history included Known allergies: Penicillin from unknown date and unknown if ongoing. The patient previously took first dose of bnt162b2 (BNT162B2, COVID 19, Pfizer, lot number: EW0198) administered in Arm Left on 24Jun2021 02:00 PM for covid-19 immunization.No other vaccine in four weeks. Other medications in two weeks included Birth control. The patient experienced had to remove my mask, felt like it was suffocating me (normally no issues with a mask)  on 16Jul2021 13:00 with outcome of recovering , broke into heavy sweat, soaked my clothing on 16Jul2021 13:00 with outcome of recovering , felt disorientated, could not get up from chair on 16Jul2021 13:00 with outcome of recovering. The clinical course was reported as follows: Broke into heavy sweat, soaked my clothing. Felt disorientated, could not get up from chair. Stayed for about a half hour. Had to remove my mask, felt like it was suffocating me (normally no issues with a mask). No treatment AE. No COVID prior vaccination. No COVID tested post vaccination.
This non serious case was received on 04 March 2009 from a health care professional.  A 74 year old female with a history of rheumatoid arthritis, hypothyroidism, hypertension, and hypercholesterolemia received ADACEL (lot number C3031AA) intramuscularly in the left deltoid on 27 February 2009.  The day prior to vaccination the patient received REMICADE.  At the injection site the patient developed an area the size of a half dollar which was red and slightly indurated.  The patient complained of burning in the area.  The patient did not have any range of motion limitations.  The patient was not recovered at the time of vaccination.  List of Documents held by Sender:  none.
Case number PHEH2014US003749 is an initial spontaneous report from a pharmacist received on 20 FEB 2014 with a follow up information received from a pharmacist on 16 MAR 2014. This report refers to an 11-year-old female patient. Her medical history and concomitant medications were not reported. This patient under the age of 18 years was vaccinated with an initial dose of 0.5 ml of FLUCELVAX (batch number: 004011A) intramuscularly in the left deltoid on 20 JAN 2014. No adverse event was reported following the medication error. No further information was provided.  Follow up information received from a pharmacist on 16 MAR 2014. Patient demographics (date of birth, age and gender) batch number of suspect vaccine and site of administration updated.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 16 MAR 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Headache x 36-48 hours - onset about 24 hours after receiving vaccine and lasted for about 2 days.  Naproxen 550mg taken but did not alleviate headache. Headache was pretty significant (about 7-8 on a 1-10 pain score). Body Aches & Chills x 12 hours post-vaccine, started within a few hours
SORE ARM; MIGRAINE; FELT A BIT CRAPPY; WARM FOR LIKE 15 MINUTES; This spontaneous report received from a patient via other company concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications were reported as patient was taking antidepressant and sleeping pills. On an unspecified date, the patient experienced sore arm (Dose number in series 1). The patient received dose 2 with Non-company suspect Moderna covid-19 vaccine (elasomeran), (Dose number in series 2), (form of admin, route of admin, batch number and expiry date were not reported), dose, start therapy date were not reported, for covid-19 prophylaxis. On an unspecified date, the patient experienced again sore arm (Dose number in series 2). The patient received dose 3 with Non-company suspect Moderna covid-19 vaccine (elasomeran), (Dose number in series 3), (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on morning of 27-OCT-2022 for covid-19 prophylaxis.  On 28-OCT-2022, the patient experienced warm for like 15 minutes, and felt a little bit crappy (Dose number in series 3) and was perfect during the same weekend. On 31-OCT-2022, the patient experienced migraine for 12 hours (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran and elasomeran was not applicable. The patient recovered from warm for like 15 minutes on 28-OCT-2022, migraine on 31-OCT-2022, and felt a bit crappy on OCT-2022, and the outcome of sore arm was not reported. This report was non-serious.
On 8/12/99 it was reported that the pt developed ulceration's on her lip and oral mucosa. The pt also developed petechiae on her arms and back.
p/vax pt exp cellulitis & hosp. Information has been received from a health care professional concerning a male who on 26-SEP-1999 was vaccinated with first dose of PNEUMOVAX. On approximately 29-SEP-1999. The patient experienced cellulitis and was hospitalized. The reporter expressed concern with the vaccine lot used. Additional information has been requested.
Vaccine was administered on 2/08/21.  Pain at injection site that day. On 2/16/21, I started to develop hives on my upper stomach region. By the next morning (2/17/21), the hives turned into large, red, swollen  welts and spread to other areas on my torso, under arms, and back of my neck. I went to an Urgent Care and was prescribed two antihistamines.  By the next day (2/18/21), the welts spread even more..  I went to the Emergency Room.  Both my heart rate and blood pressure were elevated. I was given an IV with a steroid. Upon discharge, I was prescribed  a steroid to be taken for 6 days, continue with the nighttime antihistamine for 10 days and Allegra for 30 days.