chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per Mother of child, pt developed pain, swelling and redness 2.3 hrs after injection and fever 103 degrees that evening. Pt was taken to urgent care and treated with Bactrim for a possible cellulitis (taken to UC on 9/26) Fever resolved after 2 days and redness resolved after 4-5 days.
01/28/2022 Vaccination at 11am Drove home. Was just about to sit down and eat, overwhelming sensation of sickness, vomited 3x. Malaise/fatigue rest of the day, feverish.  01/29/2022 Woke up with menstrual cycle and I haven't had for over a year. Menopausal.
Information has been received from a physician concerning her daughter, a 17 year old female who was vaccinated by injection with the second 0.5 mL dose of Gardasil.  The physician reported that her daughter had experienced a "heavy, heavy period".  The patient sought medical attention as her mother was a physician.  The lot number was not available.  No further information was provided.  Additional information has been requested.
stuffy nose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (stuffy nose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (stuffy nose). At the time of the report, NASAL CONGESTION (stuffy nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
vasovagal episode / syncope with subsequent fall to ground, striking head. lightheaded, clammy, loss of vision prior to episode. Brought to Emergency Department, discharged to home in stable condition within 5 hours.
Chills; fever; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, second dose) solution for injection intramuscular on 09Feb2021 (at the age of 48-years-old) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were unknown. Historical vaccine included BNT162B2 (Lot unknown, first dose) for COVID-19 vaccination on an unknown date with no adverse effect reported. The patient experienced chills and fever of 100.4 F in Feb2021. Treatment for the events chills and fever included two acetaminophen (TYLENOL extra strength). The outcome of the events chills and fever was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 05-OCT-2012 the patient was vaccinated with PNEUMOVAX23 (lot # H013847, expiration date unknown) dose and route not reported. No concomitant medications were reported. The physician reported that the patient experienced adverse effects of malaise, fatigue, swelling, fever and under-arm pain. The date of birth was not available for this patient nor was the specific information about the patient. The patient did not recover from the reported events as the time of this report. Treatment was not given for the events. The patient sought medical attention by notifying the physician. The physician was enquiring if there had been an increased in reports of adverse effects from this lot of PNEUMOVAX23 and was it possible that this lot of PNEUMOVAX23 was contaminated. This one of the several reports from the same reporter. Additional information has been requested.
A vial was in the fridge for more than 30 days and was given to a client; Vial was in the fridge for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A vial was in the fridge for more than 30 days and was given to a client) and PRODUCT STORAGE ERROR (Vial was in the fridge for more than 30 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (A vial was in the fridge for more than 30 days and was given to a client) and PRODUCT STORAGE ERROR (Vial was in the fridge for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A vial was in the fridge for more than 30 days and was given to a client) and PRODUCT STORAGE ERROR (Vial was in the fridge for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2022: Follow-up information received contains no new information.
Shingles in my mouth / get my shingles shot last year/ Suspected vaccination failure; Shingles in my mouth; very high tolerance for pain but this is Horrible; Cannot sleep; Cannot eat except liquids; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID-19 VACCINE. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, sleeplessness and unable to eat. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain, sleeplessness and unable to eat were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, sleeplessness and unable to eat to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. In 2020, the patient received Shingles vaccine. The patient got shingles in his/her mouth and stated he/she had a very high tolerance for pain, but this was hell. The patient went to an oral surgeon who put him/her on several medications (unspecified). The patient stated he/she hope this clears up soon and he/she could not sleep or eat except liquids. It was unknown if the reporter considered the shingles, pain, sleeplessness and unable to eat to be related to COVID-19 vaccine. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Information has been received from a consumer concerning her grandson who "2 weeks ago" on approximately 28-OCT-2010 was vaccinated with a dose of MMR II (Lot# unknown). It was reported that on an unspecified date, the patient was rushed to the emergency room with a fever of 105 that the consumer felt was caused by the vaccine. At the time of the report, the outcome of the patient was unknown. No further information is available.
Immediately after receiving  the Td vaccine I began to feel the vaccine course through my body, affecting my joints/muscles. Feeling stiffness, pain and fatigue While affecting my head as well, feeling the full affect after 20 min. It began in the arm in which the (Td) vaccine (left side)was administered. It coursed through the entire left side of my body first, then affected the right side. I was given "Thuja" remedy for symptoms (Purchased at the office at the time of vaccination).  It helped  my symptoms after 2 doses, * However I still continue to feel symptoms. They said Since I was feeling improvement, I didn't need to be seen again ( spoke via phone today 9/11/09 @ approx. 2:00PM with receptionist).
Client states evening after receiving shot, she developed a new cough that is still ongoing.  She states also developed a fever that last approximately 3 days, but has become weak and "can't hardly get out of the house" since receiving the shot.  States her PCP has been notified.
Information has been received from a physician via a wholesaler employee concerning a patient who was vaccinated with a dose of Pneumovax (lot # 651373/0320F). Subsequently the patient experienced firm area of redness at the injection site. Unspecified medical attention was sought. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Patient given PPSV23 10/12/09 mother reported soreness, pain, redness @ site and abdominal pain. Seen next day Lg erythematous area with warmth and swelling. (17 1/2 x 12 1/2 cm). Recommended ibuprofen and cool compress.
Patient with a history of adverse reaction of hives to the Moderna vaccine first dose in Jan 2021 received 1st dose Pfizer vaccine today after consulting with her allergist.  The allergist provided a letter recommending Pfizer vaccine at this point in time, rather than a second dose of Moderna.  Patient verbalized understanding and consented to receiving  Pfizer vaccine.  Patient was recommended to stay in observation for 1 hour.  Patient tolerated first dose of Pfizer after one hour with no adverse reaction.  Patient had husband pick her up.
After a month since my second dose of Pfizer, I developed a sore throat, muscle pain in arms, congestion, and a slight pressure in chest(9/15/2021). My only concern is with muscle aches, I rarely get those when I'm sick and I've never had the flu. I haven't gotten a COVID test yet.
Itchy throat and swollen tongue. Patient had similar reaction with Avalox. No reaction to 1st moderna dose.
48 hours after my daughter was vaccinated for Polio, she got an extremely runny nose and cough.  She had these symptoms for over a week and we did not take her out of the house.
Redness at the injection site, may be cellulitis, itching, Dr has prescribed her cephalexin for it.
See patient's attached letter. Patient seen by Dr. 3-10-11 & treated with prednisone 20mg 2 tabs BID x 3 days.
6:30 pm 3/17/08 fever 103.4. Complained of teeth and mouth hurting. Kept sticking tongue out and grabbing it. Dr. on call recommended Advil - took Advil then slept 11hrs.. Fever 100 in morning. No more c/o. Has continued to improve.
Varicella vaccine breakthrough. Seen in our office on 03/27/06 with fever and rash on trunk and neck. Diagnosed with varicella. Had 17 lesions.
Sent from PCP: NWMP per father to obtain vaccines.  Vaccines and VIS reviewed with father.  No prior history of vaccine complications or illness.  Vaccines provided - 10:15am.  Received phone call from father of child at 10:56am.  Noticing patient "breaking out in welts".  Denies any difficulties in breathing.  Instructed to contact PCP.  Father states went to PCP office and was informed to bring back to clinic where vaccines were received.  Father states is now at pharmacy and will be giving Benadryl.  Instructed to go to local ER (closer).  Parents notified and cell phone number for father provided.  Doctor called, instructed to go to local ER.
PATIENT CAME IN FOR 2ND DOSE OF THE PFIZER, PATIENT RECEIVED  0.2MLS DOSE FROM A PEDIATRIC VIAL.
I had Chills, 104 fever, delirious, dizzy, high blood pressure, chest pain, High dose of Tylenol, at visit was given steroids to mitigate issue.
administered 7 booster doses from a vial initially stored in the refrigerator on 16-Nov-2021 and used beyond the 30 use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 7 booster doses from a vial initially stored in the refrigerator on 16-Nov-2021 and used beyond the 30 use by date) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 027B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021 at 3:45 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021 at 3:45 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 7 booster doses from a vial initially stored in the refrigerator on 16-Nov-2021 and used beyond the 30 use by date). On 16-Dec-2021 at 3:45 PM, EXPIRED PRODUCT ADMINISTERED (administered 7 booster doses from a vial initially stored in the refrigerator on 16-Nov-2021 and used beyond the 30 use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was initially stored in the refrigerator on 16-NOV-2021 at 10:00 A.M. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
dose number: 3; I have  muscle stiffness in my legs which makes it hard to sit, stand, kneel and go down stairs; My feet are swollen; This is a spontaneous report from a contactable reporter (consumer or non HCP). The reporter is the patient. A 71 year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 12Nov2021 at 14:45 (Lot number: FH8030) at the age of 71 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing), notes: known allergies: Sulfa. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot No: Unknown), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot No: ER2613), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 12Nov2021 at 14:45, outcome "unknown", described as "dose number: 3"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset an unknown date in Nov2021, outcome "not recovered", described as "I have  muscle stiffness in my legs which makes it hard to sit, stand, kneel and go down stairs"; PERIPHERAL SWELLING (non-serious) with onset an unknown date in Nov2021, outcome "not recovered", described as "My feet are swollen". The events "I have  muscle stiffness in my legs which makes it hard to sit, stand, kneel and go down stairs" and "My feet are swollen" were evaluated at the emergency room visit and physician office visit. Therapeutic measures were taken as a result of musculoskeletal stiffness and peripheral swelling.  Additional Information: It had been 4 weeks since his third Covid vaccine at the time of reporting. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. Treatment as a result of reported events included methylprednisolone 21 pills for 6 days.
left breast was hurting; chills; body was tired, sensation that wanted to go to bed and tuck in to be warm; was cold; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (was cold), BREAST PAIN (left breast was hurting), CHILLS (chills) and FATIGUE (body was tired, sensation that wanted to go to bed and tuck in to be warm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesterolemia and Blood pressure high. Concomitant products included METFORMIN and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced FEELING COLD (was cold), CHILLS (chills) and FATIGUE (body was tired, sensation that wanted to go to bed and tuck in to be warm). On 12-Apr-2021, the patient experienced BREAST PAIN (left breast was hurting). On 12-Apr-2021, FEELING COLD (was cold), CHILLS (chills) and FATIGUE (body was tired, sensation that wanted to go to bed and tuck in to be warm) had resolved. On 13-Apr-2021, BREAST PAIN (left breast was hurting) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Additional concomitant medication included a waterpill, cholesterol medication and high blood pressure medication. These were not further specified.   It was noted by the reporter that the patient did not take medication to treat symptoms and that the patient no longer has symptoms.   At this time, no adverse events were reported after the second dose of the vaccine.
Information has been received from a healthcare worker referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates these patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L007560 with expiration 15-JUN-2017; dose, frequency and route were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
Information has been received from a 62 year old female with no pertinent medical history and no drug reactions or allergies, who in February 2008 was vaccinated with ZOSTAVAX (Merck) (lot # 659672/0294X, dose, route not reported).  There was no concomitant medication.  In June 2008, the patient experienced an outbreak of shingles mostly on her face.  The most recent case of shingles was in October 2008 and she was still experiencing it.  The patient's eyes are almost swollen shut.  The patient never had shingles before getting the vaccine.  The patient sought unspecified medical attention.  No lab diagnostics studies performed.  The events were not recovered.  No further information provided.  Additional information is not expected.    This is in follow-up to report (s) previously submitted on 12/23/2008.  Follow up information has been received from the consumer.  She stated that she had been diagnosed with dermatitis and not shingles.  Additional information is not expected.
atrial fibrillation, appeared 6 weeks after bivalent booster myocardial infarction, 6 weeks after bivalent booster vaginal bleeding s/p hysterectomy, pending workup
2/14/2023 I had shortness of breath and wheezing and I had trouble sleeping at night. The shortness of breath was in the resting position as well as exercising. I have always had a cough, but this cough was more exaggerated and there was discomfort in my lungs. It all became worse. I was thinking it was allergies. On 2/16/2023 I had a positive at home COVID test. I had a telehealth with my doctor that day and was prescribed PAXLOVID and began taking it that day. I never got worse, and everything was fine. The first of March, I went to an ENT doctor for my annual wellness check that had been already scheduled. It was a nonstarter, he did not even look at me. I talked to my Pulmonologist on 3/21/23. I did not sleep at all the night before. I was coughing, wheezing the entire night. I had an appointment with the Pulmonologist on 3/22/23. I had a breathing test and failed. I had an x-ray of my chest and was started on prednisone and erythromycin. She diagnosed it as a COPD surge and maybe bronchitis. Last night I went to bed and have not slept that good in a year.
In the AM, was very dizzy (the room was spinning whenever I changed position). My eyes felt like they were moving back and forth really fast. It made me nauseaus. The dizziness subsided sometime in the early evening, and now I have a fever (~101) and very bad joint aches (all of my joints).
she felt like she had the flu; chattering teeth; fever; shooting pains; lethargic; sleepy; no appetite; shingle like rash on her neck; This is a spontaneous report from a Pfizer sponsored Program contactable consumer or other non hcp. A 68-years-old female patient received BNT162b2 (COMIRNATY, Solution for injection, Lot No was not reported), via an unspecified route of administration on 13Feb2021 as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced she felt like she had the flu on an unspecified date with outcome of recovered , chattering teeth on an unspecified date with outcome of recovered , fever on an unspecified date with outcome of recovered , shooting pains on an unspecified date with outcome of recovered , lethargic on an unspecified date with outcome of recovered , sleepy on an unspecified date with outcome of recovered , no appetite on an unspecified date with outcome of recovered , shingle like rash on her neck on an unspecified date with outcome of recovered.  The patient underwent lab tests and procedures which included body temperature: fever   on   fever. Patient stated she was totally coherent during this time. Patient stated it lasted for 3 days and then she was fine. Patient stated she saw her HCP and wanted to know if the history was or the same for the 3rd shot. The reactogenicity profile within seven days after the booster (third) dose was typically mild to moderate. The most common events included injection site pain, fatigue, headache, muscle and joint pain, and chills. The frequency of any severe systemic event after the booster dose was low. The frequency of reactogenicity was like or better than after dose two of the primary series. The adverse event profile was generally consistent with other clinical data. Patient asked is there anything she can do or take to mitigate the reaction and stated her HCP told her to take Tylenol. The outcome of the events was recovered.  The lot number for [BNT162B2] was not Provided and will be requested during follow up.