chrisvoncsefalvay/vaers-outcomes huggingface dataset:
petechial hemes on both of my lower legs. They were inpatches as well as scattered randomly; They were deep red and purple in color and were notelevated or blister-like.; significant edema of my lower legs and ankles; fatigue; This is a spontaneous report from a contactable healthcare professional. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left arm on 19Mar2021 at 11:15 AM (at the age of 59-years-old), as a single dose for COVID-19 immunisation. Medical history included ductal carcinoma in situ (reported as DCIS), osteoporosis, psoriasis, eczema, sulfa allergy, penicillin allergy and allergy to gluten. Concomitant medications included calcium carbonate; magnesium oxide; colecalciferol (CAL-MAG-D) as a supplement from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 23:45 (one week after the vaccine), the patient experienced fatigue, petechial hemes on both of her lower legs which were in patches as well as scattered randomly. They were deep red and purple in color and were not elevated or blister-like. There was significant edema in her lower legs and ankles. Her right leg more affected than her left leg. On 27Mar2021, dermatologist suggested to get blood work to rule out low platelets. On 28Mar2021, the patient's lymphocytes were low. On 29Mar2021, the hemes seemed to be fading and leg swelling was resolved without any treatment. The patient had improvement until 31Mar2021 when new spots developed on both lower legs (looked a little different), not itchy and again fatigued. The events resulted in doctor or other healthcare professional office/clinic visit. On 31Mar2021, the patient underwent saliva pool testing and the result was unknown. The patient did not receive any treatment for the events. On 01Apr2021, the patient underwent biopsy and the result was unknown. The clinical outcome of the petechiae, purple red macule, lower leg edema and fatigue were not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Narrative: COVID infection following COVID vaccine series 03/05 COVID vaccine, Pfizer, dose #1 03/26 COVID vaccine, Pfizer,dose #2 07/29 pt cc: cough, fatigue, fever, loss of taste or smell, myalgias, rhinorrhea, dyspnea, sore throat 08/02 COVID swab, result: detected 08/10 clinically resolved
No additional AE details available.; states 10 total doses of VARIVAX (6 doses) and PROQUAD (4 doses) that have been stored outside of recommended range have been administered to patients; This spontaneous report was received from an office manager in charge of vaccine storage and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. The concomitant therapies included sterile diluent used for vaccine reconstitution.   On 28-JUN-2022, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # U039722, expiration date 15-DEC-2023 (dose, strength, route of administration and anatomical location were not provided) for prophylaxis (product storage error). The administered vaccine underwent temperature excursion of 6 Fahrenheit degrees up tp 14 Fahrenheit degrees for 50 minutes and 14 Fahrenheit degrees up to 46 Fahrenheit degrees  (15 Fahrenheit degrees) for 30 minutes on 28-JUN-2022. There was no previous temperature excursion. No additional adverse event details were available (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA000680: US-009507513-2207USA000544: US-009507513-2207USA000552: US-009507513-2207USA000553: US-009507513-2207USA000561: US-009507513-2207USA000563: US-009507513-2207USA000765: US-009507513-2207USA000771: US-009507513-2207USA000775:
Admission for altered mental status. Patient saw PCP 3/25/2021 prior to losing contact with family members. Wellness check found patient sitting in bathroom for " a couple days"
arm swelled; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 83 year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of covid vaccine), when the patient was 83 years old, for COVID-19 immunization; Bnt162b2 (2nd dose of covid vaccine), when the patient was 83 years old, for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "arm swelled".  Additional Information: Dates for arm swelled: (From: Unspecified To: Unspecified), Dates for Covid booster shot: (Start: Unspecified Stop: Unspecified), NDC number of Covid booster shot: Not Provided. Reason for no lot number of Covid booster shot: Complainant hung up abruptly/transfer incomplete. Caller, a husband calling for his wife reporting on the Pfizer Covid booster shot. Her arm swelled up and he wants to know how to treat this. Caller remarks he did not have any reaction, but her arm is swollen, and he wants to know what to do about it. Follow-up (28Oct2021): Phone Out 5:36 pm EST, 1st attempt by phone to consumer to obtain mailing information. Phone answered by the consumer, consumer does not want to be contacted any further.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up  Additional Information: Dates for arm swelled: (From: Unspecified To: Unspecified), Dates for Covid booster shot: (Start: Unspecified Stop: Unspecified), NDC number of Covid booster shot: Not Provided. Reason for no lot number of Covid booster shot: Complainant hung up abruptly/transfer incomplete. Caller, a husband calling for his wife reporting on the Pfizer Covid booster shot. Her arm swelled up and he wants to know how to treat this. Caller remarks he did not have any reaction, but her arm is swollen, and he wants to know what to do about it. Follow-up #02 (28Oct2021): Phone Out 5:36 pm EST, 1st attempt by phone to consumer to obtain mailing information. Phone answered by the consumer, consumer does not want to be contacted any further.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up #01 (28Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  Follow-up #02 (28Oct2021): This is a follow-up spontaneous report received from a contactable consumer. This consumer reported in response to non hcp letter sent via follow-up letter which included that: Upon follow up, No new AE/ was added. No other medical information was added.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Extreme dizziness 3 days after vaccine; This is a spontaneous report from a non-contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown) on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to vaccination.  The patient experienced extreme dizziness 3 days after vaccine. The patient had not been tested for COVID-19 since the vaccination. No treatment received. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Two days after second dose of Pfizer vaccine, started with pressure-like chest pain that woke him up from sleep. Made better when sat up worse when lying down. Some relief with motrin.
Pt recv vax on 1/12/99; on same day pt exp vax site red & hot
Hypoxia; Pulmonary embolism; CONFIRMED COVID-19 INFECTION; Chest discomfort; Dyspnoea; SARS-CoV-2 test positive; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority Vaccine Adverse Event Reporting System, concerned a 84 year old female patient of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: unknown) dose was not reported,1 total administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-APR-2021, the patient had severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 ) test by nucleic acid amplification (NAA) micro sented which showed positive result with shortness of breath, confirmed covid-19 infection, confirmed clinical vaccination failure, chest discomfort, dyspnoea and hypoxemia diagnosed with pulmonary embolism (PE). She was hospitalized for the same on unspecified date and discharged on 15-APR-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection, chest discomfort, dyspnoea, hypoxia, pulmonary embolism, sars-cov-2 test positive and confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000189960. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.  Additional information received from Central Complaint Vigilance department on 16-SEP-2021. The following information was updated and incorporated into the case narrative: Product quality complaint investigation result.; Sender's Comments: V2: The additional information in this version is Product quality complaint investigation result. This doesnot alter causality of previously reported events  20210832756-Covid-19 vaccine ad26.cov2.s-hypoxia, pulmonary embolism, confirmed covid-19 infection, chest discomfort, dyspnoea, SARS-CoV-2 test positive. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20210832756-Covid-19 vaccine ad26.cov2.s-Confirmed Clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
slept on and off; neck pain; I couldn't eat; sore arm; Fever; Headache; Nausea; hip pain/right hip hurt; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (slept on and off), NECK PAIN (neck pain), FEEDING DISORDER (I couldn't eat), VACCINATION SITE PAIN (sore arm) and PYREXIA (Fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included CARBAMAZEPINE for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (slept on and off), NECK PAIN (neck pain), FEEDING DISORDER (I couldn't eat), VACCINATION SITE PAIN (sore arm), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and ARTHRALGIA (hip pain/right hip hurt). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, INSOMNIA (slept on and off), NECK PAIN (neck pain), FEEDING DISORDER (I couldn't eat), VACCINATION SITE PAIN (sore arm), PYREXIA (Fever), HEADACHE (Headache), NAUSEA (Nausea) and ARTHRALGIA (hip pain/right hip hurt) had resolved.            This case was linked to MOD-2021-345452, MOD-2021-345463, MOD-2021-345452 (Patient Link).
Intermittent headache, sometimes severe.  Take Advil ibuprofen tablet by myself, relieved. While some days later, the headache came again.
Within 5 minutes of receiving vaccine, patient's (L) shoulder was red, swollen & had hives. BENADRYL given & ice applied. This halted the spread. Monitored x 20 min. & released home. Phone update next day - no further spread, but had fever of 104. (area of DTaP injection).
11/11/2021 - patient presents to EMergency Services with confusion after a recent diagnosis of Covid positive on November 6. Onset of symptoms was abrupt with gradually worsening course since that time. wife,states that yesterday the patient was normal, felt fine without many symptoms of COVID, went to bed at a normal time, and then awoke with increasing confusion.  He was unable to state his location or complete daily tasks.  His wife became increasingly worried and brought the patient in for continued evaluation. Upon arrival to the emergency department the patient was found to be confused, in acute hypoxic respiratory failure requiring oxygen therapy. Patient remains hospitalized at time of VAERS submission.
I administered MMR and ActHib, and Varivax. Pt immediately had copious rhinorrhea, cough, and hives all over his body. I administered Benadryl 50mg/ml 0.25 ml IM L deltoid and Dexamethrasane 10mg/ml 0.5ml Im L buttock, 0.6ml IM R buttock.
About 7-8 minutes after the vaccine, I got very nauseated. I remained nauseated for 3 hours. The next morning, I experienced a severe headache that lasted all day. I got a fever of over 100 degrees that afternoon. By 6pm, I was fine and felt much better.
Patient lost consciousness 5 minutes after shots given. Patient was positioned supine and comfort measures done. Vital signs within normal limits. No other symptoms at this time. patient resumed consciousness after approximately 30 seconds. 15 minutes later after slowly raising head of exam table, patient walked to chair and lost consciousness at chair, with head hyperextended and eyes oriented to left upper field with patient having snoring respirations. no tonic movements of limbs noted by myself, the reporting R.N.  Gained consciousness at approximately 20 seconds and subsequently  vomited a moderate amount of yellow fluid.  Patient talking and answering questions. EMS called and report given to crew. EMS then assumed care. patient c/o dizziness to EMS personnel.
PT CAN IN AND SHOWED ARM WITH WAS HOT TO THE TOUCH, SWOLLEN, RED, ITCHY, SHE SAID IT HAD BEEN SINCE TUESDAY AM WHICH SHE HAS BEEN ICING IT. RECOMMENDED ASHE TAKE ORAL BENADRYL AND SHE MD IF NOT BEWTTER BY A DAY OR 2.
I woke at 4:30 AM and spent the next SEVEN HOURS explosively vomiting and diarrheic. Muscle pain and tightness spread from my left shoulder, across my back, to my right shoulder. Lying flat gave me dry heaves. Standing up made me dizzy. I?m coughing like there is fluid at the bottom of my lungs. The base of my skull felt like it was in a C-clamp. My temples felt like they were in a vise. I have a rash on my shoulder and arm. I  smelled like rotting flesh. (To head off any concerns over lifestyle or hygiene, I have a BA, BFA, MBA, MSL, and completing my PhD.)  After two days of exhaustion, vomiting, diarrhea, pain, etc. I took a shower at 11:58 PM Saturday. When I swiped my soapy face towel over my left should, I wiped away a layer of skin, like a burn victim.  Be grateful I don?t have power. I would stop the Moderna injections until someone finds out what it is about my genetic makeup that might signal those with similar genetics to stay clear of Moderna.
Routine vaccination. Pt recently had a newborn enter the family and wanted to get vaccinated to protect the newborn baby.
sun burn like rash from his waist upwards on CHEST, BELLY, SIDES AND UPPER ARMS, BACK AND NECK; This case was reported by a consumer via call center representative and described the occurrence of rash in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2021, the patient received Shingrix. On 31st January 2021, 1 days after receiving Shingrix, the patient experienced rash. The patient was treated with triamcinolone (Triamcinolone Cream) and prednisone. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's wife. The patient received the Shingrix vaccine at his doctors office, and the next day had a sun burn like rash from his waist upwards on chest, belly, sides and upper arms, back and neck.  The reporter said that it was still ongoing. A biopsy was carried out and the results showed that it was something in the vaccine that patient reacted to. The dermatologist prescribed medication and treatment was still ongoing. The patient was prescribed Prednisone for 10 days, then gave Triamcinolone cream twice a day. Batch numbers was unknown. The reporter consented to follow up.
Patient felt light headed, felt like she was going to faint She lower her head between her knees She got pale sat back up and complained she felt warm, sleepy and her hands tingled she become some what unresponsive Called 911 and was transported to Hospital
The pt was given a 3rd dose of monovalent 5-11 year old COVID pfizer vaccine when the pt should have received a bivalent 5-11 year old COVID pfizer vaccine.
hot and cold at the same time; chills real bad; fever of 101.6 F for about 3 hours; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills real bad), PYREXIA (fever of 101.6 F for about 3 hours) and FEELING OF BODY TEMPERATURE CHANGE (hot and cold at the same time) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cardiac arrest (he had 2 times heart attack). Concurrent medical conditions included Diabetes.    On 25-Feb-2021 at 4:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced CHILLS (chills real bad) and PYREXIA (fever of 101.6 F for about 3 hours). On an unknown date, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (hot and cold at the same time). At the time of the report, CHILLS (chills real bad), PYREXIA (fever of 101.6 F for about 3 hours) and FEELING OF BODY TEMPERATURE CHANGE (hot and cold at the same time) outcome was unknown.
On 03/02/2021 a day after the first dose I noticed my vision was a little off the next day.  It seemed to get better and then on 04/7/2021 I noticed the sight in my right eye was again blurry.  My second dose was on 03/22/2021.  The sight in my right eye has been getting progressively worse each day.  I am now experiencing double vision.  I went to an ophthalmologist and got numerous tests performed.  After they could find the cause I was sent for an MRI which did not find the cause.
immunocompromised received a full dose for fourth dose; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (immunocompromised received a full dose for fourth dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (immunocompromised received a full dose for fourth dose). At the time of the report, OFF LABEL USE (immunocompromised received a full dose for fourth dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The physician stated he gave the order to give that patient a full dose (booster dose). Physician stated that the patient did not report any adverse effects. No treatment medication was provided.
No adverse reaction; dose of Tdap given 10/9/23 had expired 9/21/23
Post vax, the pt experienced multiple bouts of emesis approximately 30 minutes after injection.
Headache, 99.5 fever, nausea, sleeplessness, injection site pain. Tylenol was given.
Pain at injection site, expanding and radiating down arm. Pt. also has intermittent fevers (low grade), chest congestion and throat pain.
This was an vaccine administration error by the LPN administering the vaccines. Not realizing the difference between the Purple Cap monovalent vaccine and the orange cap monovalent vaccine, the nurse administered an adult dose to a person under the age limit for Pfizer BioNTech vaccines. The nurse claimed that she looked up to see if the vaccine type was correct for someone that young, but did not research or inquire the dosage after seeing that the orange capped vaccine was
headache resolved, sore throat resolved, productive cough at times, fever 100.4 Friday, body aches, loss of taste, loss of smell, diarrhea, nasal congestion, post nasal drainage, chest congestion. starting on 11/12/21.  LOT numbers not available on her chart
Reporting arm soreness beginning day after injection and continuing up to and including 9/27/13. Painful and hard to move arm initially; getting better but still sore.
Gave Moderna to a 12 year old.  Mother contacted and per information earlier received will give Pfizer for second dose when she returns for second dose.
approx 8 mins p/pt had recvd vax becam ill in car while still in parking lot; staggered back into the building & collapsed by entrance to med records; BP 80/42, P42 @ time of fainting; by 505PM BP 110/60
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 18-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # L040460, expiration date 27-MAY-2017, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 80 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.