chrisvoncsefalvay/vaers-outcomes huggingface dataset:
an allover body rash; The caller states it is hard to read; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 42-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: unknown) via an unspecified route of administration on 28Apr2021 at 12:00 p.m. (at the age of 42-years-old) as dose 1, single for COVID-19 immunisation. Prior and since vaccination patient has not been tested for COVID-19. No, other vaccine in four weeks. The patient medical history and concomitant medications were not reported. Patient didn't had any known allergies. On 29Apr2021 at 12:00 a.m. the patient experienced an all over body rash and on unspecified date of 2021 the caller states it was hard to read. Therapeutic measures were taken as a result of an all over body rash. The caller was a consumer reporting patient has questions and was hoping Pfizer can help. After the caller received patient first dose Pfizer Covid 19 Vaccine, the caller had an all over body rash. The patient has been to doctors visits. patient was now scared to received the second dose Pfizer Covid 19 Vaccine and is not sure what to do. Patient received the treatment for events. On 19Jul2021, this follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. The outcome of events is not recovered.  Follow-up attempts completed. No further information is expected
contracted shingles; This is a spontaneous report from a contactable consumer report for self. This 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient said she was due tomorrow for her second dose but she has contracted shingles this week (in Apr2021) and started on Valtrex medication for it 2 days ago. Event outcome was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On 3-25-04 pt was seen for WCC and immunes on 3-26-2004 pt returned to clinic with complaint of red & swollen right upper arm. The pt did not have a fever & states that her arm did not hurt when it was touched. Pt mom was instructed to used warm compresses & give Benadryl as needed. She was to follow up on 3/28/04 but cancelled the appt.
positive COVID test on 21Sep2021; positive COVID test on 21Sep2021; woke up with a sweat on 20Sep; Felt not well on 19Sep; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN0150) via an unspecified route of administration in left arm on 21Apr2021 (at the age of 32-year-old) at single dose for COVID-19 immunisation. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN0150) via an unspecified route of administration in left arm on 31Mar2021 (at the age of 32-year-old) at single dose for COVID-19 immunisation. Relevant medical history included psoriasis. Concomitant medications included multivitamin. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 19Sep2021 the patient felt not well and woke up with a sweat on 20Sep2021. On 21Sep2021 he was diagnosed with breakthrough positive COVID test. No treatment was received. Nasal swab (antigen test) on 21Sep2021 was positive. The patient was recovering at the time of report.  Follow-up attempts are completed. No further information is expected.
Following the vaccine patient had pain in her arm with numbness and tingling. She became lightheaded, dizzy, and had nausea. She reported visual disturbance with the lights becoming very bright. She then had nuchal rigidity and headache. She became very lethargic and was unable to stand, sit up, or keep her head up. She could not keep her eyes open for more than a few seconds. Vital signs taken on site were: BP:176/107, Pulse 77, O2 on room air 99%. EMS was called transported her to Emergency Room.
my vision became blurry within one hour of dose. In addition , I had 2 irregular heartbeat scares. One within one month of vaccine and the other 5 months later.
I noticed a large bright red band of oozing, painful, itchy, burning, yellow fluid-filled vesicles around my left ankle, extending to the top of the foot and below the knee. Some vesicles popped, exuding a large quantity of fluid that dried flaky if left on skin. Vesicles were not painful to open. The number and size of the vesicles and affected area has not changed since outbreak on 7/7/18 (1 weeks' time).
pt recv vax & devel chills;pt devel gen myalgia, became emotionally unstable, began crying & devel a sl fever 99.2;pt is currently exp a h/a;pt tx w/APAP;
Expired vaccine was stored and then administered; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that vaccine did not undergo any temperature excursion and patient did not experienced any adverse event and the date vaccine placed in refrigerator was on  26-Oct-2021.
The evening post vax, began having hot flashes. During the days following complained of chills, fever, loss of appetite, congestion, sore throat and runny nose. This resulted in loss of duty for 48 hours.
Injection site and surrounding  area is red, swollen, itching  and warm to touch. Spoke with NP, via online portal, who stated to keep an eye on area.
Stiffness L knee, left wrist Lon back of hand at L wrist area. systemic rash
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, on an unspecified date (Batch/Lot number: unknown) at an unspecified age as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown", described as "had a seizure and her sister rushed her to the hospital and they said it was not related to the blood sugar". The event "had a seizure and her sister rushed her to the hospital and they said it was not related to the blood sugar" was evaluated at the physician office visit and emergency room visit. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202200494170 same reporter/drug, similar events, different patients
Patient is fully vaccinated, boosted, and up to date on COVID-19 vaccinations. He was admitted to the hospital for treatment of COVID-19 on 12/25/2022. His onset of symptoms was on 12/24/2022 with chills and diarrhea. He tested positive for COVID-19 on 12/25/2022 at the hospital.   No treatment information was provided. Submitter does not have access to further medical information on this case. If more information is needed, please contact the admitting hospital.
Information has been received from a physician concerning a 12 to 15 month old female who, in the "past month", January 2006, was vaccinated with a 0.5 ml subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot# 650233/0912R). "Two weeks ago", " a few days" after vaccination, on approximately 01 February 2006, the patient experienced breakthrough lesions. Unspecified medical attention was sought. No product quality complaint was involved.  Additional information has been requested.
For two weeks and counting: muscle ache-severe; joint stiffness/aches; loss of weight; no energy; lots of unusual sleep.
Pt started running fever 03/29 101.2, on 03/30 103.5, on 03/31 mom noticed blisters/bumps on pt body. 14 days to the day after her immunization
Pt received TDAP 4/27/09 and tested positive PCR for Pertussis on 3/04/10.
Initial onset of symptoms: 09/13/21: migraine-like headache, nausea, dizziness, small red patch at injection site, mild itchiness, arm very sore, couldn?t raise it above my chest, appetite suppressed. ibuprofen helped a little with headache, and soreness, not with itch,  Two weeks later:  large red, raised, swollen area from injection site to elbow, extreme itching, tiny bumps, mild headache, nausea, dizziness. still taking ibuprofen for headache. Benadryl helped with itch and swelling. After two weeks more, upper arm a light pink, mild itch continues .
After vaccines were given patient was getting off of the examination table she began to feel weak and then passed out. Pallor in color once we brought her to the floor she began to wake up. Vital signs were stable at that time....patient became alert few seconds after event did not recall what happened.  Cold compresses applied to patients forehead.  Patient kept stating "I just want to sleep".  After approx 1 hour patient was alert and oriented but still drowsy...water was given.  Patient stated she didn't eat anything for breakfast we attempted to give her some crackers.  Finally without any intake of crackers patient began to feel nausea and was trying to vomit without success.  At that time Dr. advised for patient to be brought to the ER for evaluation.  EMS called and patient brought to ER via ambulance with parent following in her own car.
All adverse effects were believed to onset in the first 1-2 days after vaccination, and are still ongoing 10 days later, but not reported to be severe: sore arm, fatigue, nausea, vomiting, chills, fever (mild), shaking, dizziness, syncope ( none recent), wheezing, pain in left trunk area upon deep inhalation (not sharp), cough, sputum that is sometimes brown. The parent came close to taking her to the emergency room earlier on after vaccination, but did not.
I recently took the IGM test and it came with a result of  1000 instead of the expected average 300; This is a spontaneous report received from a contactable consumer. This consumer (patient) reported that this patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date single dose for COVID-19 immunization. Medical history and concomitant drugs were not provided. Historical vaccine included flu shot a month before. The patient recently took IGM test and it came with a result of 1000 instead of the expected average 300. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
nurse was supposed to vaccinate 3 patients with Adacel, however vaccinated them with Daptacel instead in error with no reported adverse event; Vaccine was given to the wrong patient with no adverse event; nitial information received on 16-Sep-2021 regarding an unsolicited valid non-serious case from a consumer/non health care professional and physician via Media Information (under reference 00773251).  This case is linked to cluster cases 2021SA309592 and 2021SA310131.  This case involves a 12 years old male patient who received DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [ADACEL] (wrong product administered and product administered to patient of inappropriate age).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) [lot number and expiration date were not reported] via unknown route in an unknown administration site for prophylactic vaccination.  On 17-Aug-2021, the patient received a 0.5 mL dose of suspect DAPTACEL (TOTAL, lot C5687AA and expiration date: 09-Dec-2021) via intramuscular route in the deltoid for prophylactic vaccination.  It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (same day latency).  It was reported "Director of Quality stated DAPTACEL ( 253 - DAPTACEL) was given to the wrong patient population and wanted recommendations. Caller stated ADACEL was supposed to be administered. Director of Quality states that a nurse was supposed to vaccinate 3 patients with Adacel, however vaccinated them with Daptacel instead in error. The caller asks if the patient's should be injected with Adacel now, or if the Daptacel was sufficient. The caller states that this occurred because the Daptacel and Adacel sound the same."  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements. 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.
16Jan91-Mom here for shots states pt was sick /p recving those 1st shots.Pt was foaming @ the mouth &crying &had the shakes.Pt was screaming,not crying for long time.Didnt take to MD,had a little T but didnt take it.Mom gave pt Panadol.
I felt a bit under-the-weather for several days after the 1st vaccine dose, but felt terrible for nearly 2 weeks after the second dose, given 4 weeks later.  Also my left arm developed a red rash in an irregular pattern from my shoulder to wrist.  I called our family doctor's office.  A staff member advised me to put an ice pack on my arm for several days to reduce the irritation.  Two and a half months later, there is still a red mark at the site of the 2nd vaccination and occasional deep pain in the upper left shoulder area.  I reported the issues to Moderna immediately and spoke with a gentleman collecting data for them.  I subsequently filled out a formal report form sent by a Moderna office.  All five people in our family have had their COVID vaccinations.  Two received the Pfizer vaccine and had minimal discomfort, 1 had the J&J vaccine with minimal discomfort and 2 of us had the Moderna--and were miserable for an extended period of time after the second dose, with myself having lingering issues.  I am submitting this report because I am concerned about the approval of the Moderna half-strength booster vaccine.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Additional Details: Very large, red, warm, swollen, demarcated skin reaction/rash extending from the shoulder to elbow.
EXPIRED VACCINE GIVEN. TREATMENT WAS TO REPEAT VACCINE PER DR'S ORDERS. NO ADVERSE EVENT SYMPTOMS NOTED
The patient had syncope a few minutes after the injection. They were unconcious for approximately a minute before regaining conciousness. They told me that right after the shot, they had a few moments of nausea which went away quickly. They then had a 'high-like' sensation before losing conceousness. After regaining conciusness, they had no further symptoms until the next day (today). They are feeling drowsy, achy bones, and headache. They said they would contact me if they experienced further symptoms.
This case was reported by a consumer via call center representative and described the occurrence of pain in a 52-year-old female patient who received Flu Seasonal TIV Dresden (Influenza vaccine unspecified 2012-13 season) for prophylaxis. On an unknown date, the patient received Influenza vaccine unspecified 2012-13 season. On an unknown date, 1 day after receiving Influenza vaccine unspecified 2012-13 season, the patient experienced pain, loss of energy and mobility decreased. On an unknown date, the outcome of the pain, loss of energy and mobility decreased were recovered/resolved. It was unknown if the reporter considered the pain, loss of energy and mobility decreased to be related to Influenza vaccine unspecified 2012-13 season. Additional details were reported as follows: The age at vaccination was not reported but it could be 51 or 52 year old. In 2012 or 2013, the patient received the flu shot. The next day she was laying on the floor all day with achiness, no energy and motionless. The patient symptoms were resolved after one whole day. This reporter consented to follow up. This case has been linked with case US2019040214, reported by same reporter and having same patient.
Bell's Palsy; This is a spontaneous report from a contactable nurse. A 33-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter reported a patient developed Bell's Palsy after receiving the first dose of the vaccine. This patient was a physician, the reporter stated that the patient was scheduled to receive the second dose on Monday (unspecified date) and questioned if he should or should not get the second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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.
In a few minutes after vaccine administration , pt vomited a small amount and felt hot for few minutes. pt started feeling better after few minutes and was monitored for at least for 15 minutes.
Hives on neck, shoulders, arms and abdomen; This non-serious case was reported by a other health professional via call center representative and described the occurrence of hives in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (She had no adverse effects after the first Shingrix dose on 12-JAN-2023).   On 14-APR-2023, the patient received the 2nd dose of Shingrix (intramuscular, unknown deltoid). On 15-APR-2023, 1 days after receiving Shingrix, the patient experienced hives (Verbatim: Hives on neck, shoulders, arms and abdomen). The patient was treated with cetirizine and prednisone. The outcome of the hives was not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.     It was unknown if the company considered the hives to be related to Shingrix.   Additional Information: Additional Information: GSK Receipt Date: 18-APR-2023 The reporter was physician's office manager who reported that, the patient had received her second dose of Shingrix. One day later, she developed hives on her neck, shoulders, arms and abdomen. She presented to the physician's office today (on the day of reporting) and the hives were treated with cetirizine and prednisone.  Nothing else was reported. The vaccine administration facility was the same as primary reporter. The reporter had consented to follow-up. This case was linked with US2023056839, which was reported by same reporter.; Sender's Comments:  US-GSK-US2023056839:Same reporter and different patients
Information has been received from a physician concerning a female patient who was vaccinated with a dose of GARDASIL. Subsequently the patient fainted after receiving the GARDASIL. The patient had recovered (date unspecified). The patient had sought the physician for medical attention. This is one of several reports received from the same source. Additional information has been requested.
I have huge red itchy hives from head to toe. I went to the ER Saturday and Sunday. Nothing is helping. I?m taking prednisone, Pepcid, benedryl, ibuprofen, Allegra and Zyrtec. I am so miserable.
Extremely irritable and unable to weight bear on vaccinated leg. Leg became limp and she would scream if we touched it.
Developed arm soreness within few hours of vaccination approximately 12 hours after vaccination, severe arm pain, swelling to shoulder/deltoid/trapezius. Place on anti-inflammatory medication and 7-day course of antibiotics.
was administered expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 9-week-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 75M9B, expiry date 11th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 20th July 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 20th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-JUL-2022 Reporter's Comment: The reporter was medical assistant, calling on behalf of the patient.  The reporter reported that the patient was administered expired Rotarix.  The reporter reported that, no adverse reactions had been observed. The reporter consented to follow up. Additional Supportive Information: The patient was administered expired Rotarix, which led to expired vaccine used.