chrisvoncsefalvay/vaers-outcomes huggingface dataset:
site of injection is itching; site of injection has red mark (5 inches long); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (site of injection is itching) and INJECTION SITE ERYTHEMA (site of injection has red mark (5 inches long)) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029KC20A and Unknown) for an unknown indication.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced INJECTION SITE PRURITUS (site of injection is itching) and INJECTION SITE ERYTHEMA (site of injection has red mark (5 inches long)). At the time of the report, INJECTION SITE PRURITUS (site of injection is itching) and INJECTION SITE ERYTHEMA (site of injection has red mark (5 inches long)) had not resolved.            Patient received the treatment drug cortozone-10 cream
Glaucoma; Frog in Throat/ Lump feeling in throat; eye problems/ saw two figures instead of one when driving and watching television/ double vision; Started Leaking Liquid/ Wound secretion; Bruised Leg/ Bruising of leg; Arthritis; This is a solicited report based on the information received by Pfizer Mfr. Control No.: 21K-163-4087842-00). A contactable consumer (patient) reported that a 90-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unknown dose for moderate to severe rheumatoid arthritis. The patient medical history and concomitant medications were not reported. The patient experienced events of non-serious frog in throat/ lump feeling in throat, verge of glaucoma, eye problems/ saw two figures instead of one when driving and watching television/ double vision, Bruised Leg/ Bruising of leg/ Started Leaking Liquid/ Wound secretion and Arthritis. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Reporter causality for bnt162b2 with events Lump feeling in throat, Glaucoma, Double vision, Wound secretion, Bruising of leg, Arthritis was possible. The action taken in response to the events for adalimumab was unknown.The outcome of the events Glaucoma and Wound secretion was unknown, other events was not recovered.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient received / first dose 2 years ago / never received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date, 2 years ago from reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist technician called to ask about Shingrix schedule if a patient received Shingrix first dose 2 years ago. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No information on the exact vaccination date of first dose was reported. The reporter consented to follow up.
Nausea feeling, tired followed by chills, sweats and shivering.  Followed by itchy palms of both hands, feet and thighs.  Eventually my whole body itched.  With hives.
Patient potentially received a dose of vaccine that was improperly stored. No reported effects. Following up with manufacturer for guidance.
I have had migraines my entire life, so no stranger to headaches.  But, immediately after the vaccine I had ?metal mouth?.  This did go away.  However, I have had severe migraines like I have never had before and in a different location in the head that usual.  The severity is scary and there are no neurologists that have available appointments to review this with me until February 2022.    Is this a common side affect that may remain for months?  I have had four excruciating migraines since I was vaccinated.  Never had anything like it.  No doctors in the area that can help, somewhat rural area.  Thank you.
Sore throat right away. Eyes hurt red itchy eyes swelled nearly shut for 48 hours. No medication taken.
Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Additional Details: Patient complained of nausea, palpitations, heart pounding symptoms, sweaty palms and the back hurt.  BP 152/99, after approx 1 hour the BP when down to normal
Shingrix adjuvant only administered; Inappropriate dose of vaccine administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number HL9AJ, expiry date 04-AUG-2024) for prophylaxis.   On 12-MAY-2023, the patient received Shingrix. On 12-MAY-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix adjuvant only administered) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 12-MAY-2023 The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was same as the primary reporter. The reporter did not consent to follow up.
Pt received 3 vaccines, TYPHIM IV, TWINRIX, Yellow Fever and developed rash all over body after 7 days. Received MEDROL DP from Dr. Dr not sure if pt had reaction to vaccines.
5MAR93 pt given APAP drops approx 30 mins p/vax; 2PM 5MAR93 had t101-102; 4AM 6MAR93 t104-105; pt taken to ER;
Red papular rash over trunk arms since 9/26/09. 9/28 T-101.4
Extra dose of MMR given.   Adult patient (30 years old) walks in for college immunizations screened for previous last names at visit, denies previous names. After giving, vaccines, vaccines would not transfer, report states there is another matching client. Clinic emailed to merge accounts. After emailing clinic a clerk found a 3rd account. Patient questioned, states she only gives by the last name, not her married name.
Patient received COVID 19 1st dose (Pfizer) and was waiting  on chair outside pharmacy. She started to look pale and experiencing syncope. Her friend was trying to talk to her while pharmacy staff tried to contact 911. After pharmacist also tried to keep talking to her, she suddenly regained composure and consciousness. She drank some water and was monitored for another 30 minutes before leaving. Pharmacist followed up after 3 days and patient is doing  fine. Patient has history of syncope from anxiety inducing events and did not have anything to eat that morning  which may have contributed to the syncope. She stated that she was still partially conscious during the event.
Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 04Mar2021 (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: DIZZINESS (non-serious), outcome "unknown", described as "Dizziness".  Additional information: The patient is worried about getting the second dose. The patient has read that side effects could be worse in second dose and she wanted to know if she should get the second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from an approximately 71 year old female patient with no pertinent medical history. Current condition of the patient included codeine allergy. On 19-JUN-2012, the patient, was vaccinated with dose 1 of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified) without any symptoms. On 20-MAY-2013, the patient was vaccinated with dose 2 of PNEUMOVAX23 (lot number and expiry date reported as H017759 and 04-JUL-2014 respectively, dose and route unspecified) in the left arm. Concomitant medication included blood pressure medicine (unspecifie). Approximately on 20-MAY-2013, the patient reported that it was extremely hurtful going in with a warm tingling sensation. Within 3 hours hour, arm began to turn beet red and swell. Within the next 24 hours she had severe muscle aches, could barely life her arm. She was drowsy, severe arm pain from elbow to neck, stiff neck, felt feverish, total discomfort, restlessness. It was painful to walk or move. The patient sought medical attention (called the doctor) and she was prescribed with cold compress and ADVIL (dose and manufacturer unspecified). Routine blood work was performed prior to the injection on the same day (20-MAY-20130 and the result was unknown. The patient was recovering from all the events at the time of reporting. The relatedness for all the events was unknown for PNEUMOVAX23. Additional information has been requested.
Info has been received from a physician and a school nurse concerning a 13 month old male between the 2nd and 5th grad who on 11/13/95 was vaccinated with a dose of varicella virus vaccine live. It was noted that the pt also received a dose of MMRII on 11/3/95 (within 30 days of varicella virus vaccine live. A school nurse reported to the physician that the child developed a mild cases of breakthrough varicella with less than 50 lesions. Unspecified medical attention was sought. A product quality complaint was not involved. Follow-up info indicated that on 3/24/05, the pt developed a mild case of breakthrough varicella. The outcome was reported as recovered. No additional info is expected.
1st vaccine: pain to immediate area that lasted approx 4 days; headache. 2nd vaccine: severe headache within a couple of hours, chills all night (about 14 hours after vaccination); pain to area (not as bad as 1st time); golf size protrusion next to armpit, swelling under arm pit, pain to armpit area and sensitivity; tired first 2 days and then exhausted day 5 and 6; rash next to armpit of other arm.
lost of appetite; runny nose; feel very tired, has struggle doing anything; fever between 100.7- 100.8 °F; has struggle doing anything; sore right arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Jan-2021 and was forwarded to Moderna on 19-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (has struggle doing anything) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O12AO20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported historical condition). Concomitant products included Cholesterol medication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (has struggle doing anything). At the time of the report, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (has struggle doing anything) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Body temperature: 100.7-100.8f (High) Since 15Jan2021, patient has been experiencing fever between 100.7- 100.8 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment taken included acetaminophen.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Initiative
This spontaneous report as received from a pharmacist (also reported as physician) via a company representative refers to a 78 year old male patient. Concurrent conditions and medical history of the patient were not provided. On 31-JUL-2012 the patient was vaccinated with ZOSTAVAX vial, of dose 0.65 ml, subcutaneously (lot# not reported). Concomitant medication was not specified by the reporter. On 04-NOV-2015, 1192 days after onset of therapy the patient experienced post herpetic neuralgia (PHN), pain and significant rash. The patient sought for medical attention (unspecified). The outcome of post herpetic neuralgia was unknown. The outcome of rash was resolved, but the outcome of pain was not resolved, according to the Pharmacist. Causality statement was not provided by the reporter. No product quality complaint (PQC) was filed. Additional information has been requested.
Patient dx with vasculitis from the trunk down. Patient went to the ER twice and the Doctor twice.  Patient does have some bruising. Patient took  Prednisone for 2.5 weeks.
Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 10Jun2021 10:30 (Lot Number: EW0186; Expiration Date: Aug2021) as dose 1, single for COVID-19 immunization at the age of 65-year-old. The patient received the COVID-19 vaccine in hospital. Medical history and concomitant medications were none. No family history. The patient did not receive any vaccinations prior to COVID vaccine. The patient did not undergo any relevant tests. The patient experienced diarrhea and stated that its looks like it is water on an unspecified date of Jun2021 (reported as about 4 days ago). The event did not result in any emergency room or physician office visit. It was reported the event was persisting (not recovered). She is scheduled for the second dose on 01Jul2021.
This spontaneous report was received from a medical assistant and refers to a 23-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unspecified day in 2007 (reported as 11 years ago), the patient was vaccinated with the first dose of GARDASIL 9 (dose, route of administration, lot number, expiration date were not reported). It was reported that on 14-AUG-2018, the patient was in the office to receive her second dose of GARDASIL 9 (unspecified lot and expiration date). There were no adverse effects.
Late in the evening on the date of my second shot, I experienced cold chills and unsound sleep overnight.  No adverse issues the day after the second shot..
8-days post vaccine, I developed a raised, red mark at injection site.  The visibly red area was originally the size of a mosquito bite but the tricep area overall was swollen and hard.  Within 8 hours the redness expanded to an irregular shape, about 4 inches x 2 inches.  Mine did not itch, but was raised and blotchy and tender to the touch.  After reading about "Covid Arm" on some medical sites, I took a Zyrtec antihistamine .  The symptoms resolved within 2 hours.
No adverse event; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an 18-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medications were reported.  Treatment information was not provided. ID: 80777027399
28MAR96 pt had a 5cm hard, red, warm  area  @ the site of inj which was first noticed 26MAR96;t98;primary care physician prescribed cold compresses & an ATB began to resolve p/2 doses
Patient experienced 100 degree fever, chills, shaking for 24 hours. Sore arm for 3 days
Right anterior thigh swelling of entire thigh to nearly double the normal size per parent report. Area warm to touch. Anterior portion hard. Parents to watch and have evaluated for any exacerbation. Note: Afebrile, circulation good, playful.
Information has been received from the Merck pregnancy registry for GARDASIL from a physician concerning a 17 year old female who on 16-JUL-2007 was first vaccinated with 0.5 ml, GARDASIL.  Concomitant therapy included albuterol which the patient used infrequently.  On 17-SEP-2007, the patient presented to the office to get her second dose of GARDASIL but a urine test showed positive HCG and the client was pregnant (LMP 18-AUG-2007).  The second dose of GARDASIL was not administered.  Followup phone call information from a pediatrician reported that the patient had not been back to the pediatrician's office since she found out she was pregnant.  However, the pediatrician was able to report that via their tracking system, it appeared that the patient was still pregnant and had an upcoming appointment.  She also reported the patient had been admitted to the hospital for pre-term labor from 28-MAY-2008 to 31-MAY-2008.  No outcome information was reported.  Additional information has been requested.
Developed symptoms of SARS-CoV-2 infection including shortness of breath, cough and was tested due to persistence of symptoms despite antibiotic treatment. Antigen testing was positive. Approximately 1 week after symptom onset patient was noted to be lethargic and confused by family who contacted EMS. Patient was hypoxic in ER and required 8 L of O2. Was admitted with COVID-19. Subsequently did decompensate on the floor and required intubation. Currently intubated receiving remdesivir, dexamethasone, and antibiotics.
client given Pfizer Covid 19 vaccination that had been thawed 35 days prior to administration. Contacted manufacturer. Vaccine is considered stable at time of administration.
got the shingle shot and still got the shingles/Suspected vaccination failure; Shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shingle shot and still got the shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-JUN-2023 The case was received from the patient via interactive digital media. The patient still got the shingles after receiving the Shingle shot. It did a lot of good to him/her. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Pt developed a fever of 105 within 48 hours of vax. No specified findings.
Information has been received from a physician, via a company representative, concerning a female patient (age not reported), who on an unspecified date was vaccinated with a dose of Gardasil (lot # not reported).  The physician stated that "about" two weeks after the vaccination, the patient "had a lot of soreness in her arm."  At the time of this report, the outcome of the event was unknown.  The patient did not require medical attention for the event.  Additional information has been requested.
The pt experienced a fever on 7/13/01 which continued until 7/16/01. On 7/18/01 developed a severe debilitating headache. Pain was on "top" of head. Pain was so bad it caused the pt to hyperventilate and become very dizzy.
This spontaneous report as received from a medical assistant refers to a patient of unknown gender and age. Information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was not reported. In October 2013 (reported as: "3 years ago"), the patient was vaccinated with the first dose of GARDASIL (dose, route of administration, lot# and expiration date were not reported). On 24-OCT-2016, the patient appeared in the medical assistant's office to receive a dose of GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported), as the second dose in the HPV series, which was outside the prescribing information for both vaccines. No adverse effects were reported. Additional information has been requested.