chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; Fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HEADACHE (headache) and PYREXIA (Fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 069F21A, 005C21A and 021B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and PYREXIA (Fever). At the time of the report, HEADACHE (headache) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported.   It was reported that,the patient was in her mid 50s, patient usually experienced the normal headache or fever reaction 48 hours after she receive previous shots.  No treatment details were reported.   This case was linked to MOD-2022-656151 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2022: Live significant follow up received contains vaccination details and patient name were reported.
Information has been received from an unspecified reporter referring to a 14 month old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 10-AUG-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Health Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Circulation bump, about 1 in across. The bump has been present since injection but became and slightly warm to the touch 7 days after injection.
Fever blisters, Shingles, AFIB event.  I took valtrex for the fever blisters which also kept the shingles from spreading.  The AFIB was on the Saturday evening after the shot on Monday.  I went to the emergency room where it was controlled by medication.  This was the first heart event in my lifetime.  I spent the next months doing tests and seeing a cardiologist.  I have not had another event since the week of the vaccine.  I am to see my cardiologist one a year as followup.
The day after my 2nd vaccine, I was in excruciating pain in my right arm, hand and fingers.   It felt like someone had driven a nail into my hand (and I'm not a Christian).   As of today, my hand and fingers are almost completly numb and my fingers tingle all the time.   I was given a sterioid treatment, prescriptions for Gabapentin, Tizanidine, and Hydrocodone after days of being in bed with debilitating pain.   I am no longer on the steriod, and can function without the Hydrocodone.   However, I continue to take the Gabapentin and Tizanidine because I have a completely numb right hand with painfully tingling fingers.   Every day is a challenge for me to function because I often feel stinging pain at the injections site along with shoulder pain, in addition to the pain in my hand and fingers.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 55-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm left, administration date 03Mar2021 14:00 (Lot number: EL3248) at the age of 55 years as dose number unknown, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PRAVASTATIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Mar2021 18:00, outcome "recovered" (04Mar2021), described as "Arm soreness at injection site"; HEADACHE (non-serious) with onset 03Mar2021 18:00, outcome "recovered" (04Mar2021), described as "Slight headache"; FATIGUE (non-serious) with onset 03Mar2021 18:00, outcome "recovered" (04Mar2021), described as "Fatigue". Therapeutic measures were not taken as a result of vaccination site pain, headache, fatigue.Additional information: The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. The events did not result in death, were not life-threatening nor disabling/incapacitating, and did not cause/prolonged hospitalization nor result in congenital anomaly/birth defect.Follow-up attempts are completed. No further information is expected.
I was sneezing quite a bit, not feeling very well, tired. It felt like a cold. I was very fatigued but only lasted for a couple of days. I took a home COVID-19 test that came back positive. I made an appointment with my PA, I was retested there in the office with a PCR COVID-19 test it also came back positive. We decided against any medication, I just stayed hydrated and rested. I retested on the 23rd was negative.
Initially my sodium levels were low and I experienced shortness of breath, lightheadedness, dizziness, diharrea, chest pains.  The sodium levels corrected in a few days with fluid restriction.  Chest pains, dizziness, lightheadedness,  brain fog, sharp pains in my head, tingling in hands and feet, insomnia have all persisted.
Parents described "jerking movements" lasting less than 15 minutes on 1st day. Recurrence of seizure on day 2, taken to ED. Recurrence on day 3 x2 taken to ED where another seizure was witnessed per staff.
Rhabdomyolysis with myalgia, fever and fatigue. Pt was hospitalized for cpk  >123,180 and given IV fluid hydration.
A dull pain and tight feeling in the chest occurred after the vaccine when physical activities were engaged in, such as fast walking and dancing. These were common exercise activities that began to result in pain in the chest. Blockages were discovered in the heart and two stints were placed in two arteries.
Patient came in to pharmacy 3/18/18 reporting a rash on forearm. There was a dime-sized spot blister-looking spot on forearm. Patient reported no itching or pain.
I have a dr appt next week, I did have some mid numbness on the top of my leg that I have had for a while, thought it might have been related to my knee surgery over 10 years ago, and developed leg cramps that I contributed to my diet most recently, so not sure if this is related or just bad timing
Hospitalized 01/07/2022; COVID-19 positive 01/07/2022; fully vaccinated  Admit Date: 1/7/2022 12:29 PM Discharge Date: 1/10/2022 Hospital Course: Patient is a 66 y.o. female with past medical history significant for chronic obstructive pulmonary disease, diastolic congestive heart failure, chronic respiratory failure on 2 L of oxygen in the outpatient setting, morbid obesity, presented to the emergency department with chief complaint of fever, nausea with vomiting and cough.  Patient was residing at a skilled nursing home since a motor vehicle accident last year.  Patient's roommate was recently diagnosed with COVID. Patient reported increased shortness of breath, cough, and fever.  Patient's oxygenation was at 70% prior to arrival but was not wearing her home oxygen.    In the emergency department patient had a low-grade temperature of 99°, blood pressure and heart rate were reassuring.  Patient was oxygenating 96% on 3 L nasal cannula (baseline).  Patient had leukocytosis with elevated white count of 21.4.  COVID-19 PCR was positive.  Chest x-ray with evidence of bilateral patchy infiltrates and mild pulmonary vascular congestion.    Patient was started on IV azithromycin and cefepime with concern for healthcare acquired pneumonia given patient's status as a nursing home resident.  Blood cultures were obtained.  Patient was admitted to Hospital for further management.   As patient was requiring supplemental oxygen patient was started on remdesivir and dexamethasone.  As patient's oxygen requirements but at baseline days were discontinued on day 2. Patient continued to improve clinically.  Patient was transitioned to oral Augmentin to treat pneumonia.  Patient was placed on sodium and fluid restriction for chronic congestive heart failure.  Patient was discharged to long-term care facility in stable condition.
Patient contracted Shingles. Rash, nerve pain. Treatment was with Valacyclovir 1 gram with instructions of 1 tab by mouth three times daily for 7 days and Gabapentin 300 mg with instructions of 1 cap by mouth three times daily for 30 days.
(L) thigh 5"x3" area of redness, bruising, firm in center. No itch. Tx ice/ibuprofen/Augmentin ES 600/5 - 4 ml BID x 10 d.
Information has been received from a registered nurse concerning a 24 year old female student (weight 113) who on 19-MAR-2007 was vaccinated with the first dose of Gardasil, IM in the left deltoid (Lot number 657006/0188U). Concomitant medication was not reported. On 19-MAR-2007 in the evening, the patient developed a rash on her neck and abdomen. There was not reaction at the injection site. The patient was treated with Benadryl. Subsequently on 30-MAR-2007, the patient recovered from a rash on her neck and abdomen. Follow-up from a dermatologist indicated that the patient had a medical history of laser treatment to the cervix and was on birth control pill concomitantly. The patient was seen in the office on 02-APR-2007 with multiforme rash of the torso and neck. The dermatologist reported that the patient indicated that the rash began the evening that the patient was vaccinated. The rash started 2 weeks before it was assessed by the dermatologist. The physician reported that the patient was treated with oral steroids to prevent serious criteria. The patient has recovered. The dermatologist reported that the multiforme rash was an other important medical event. Additional information is not expected.
Vaccine is mistakenly administered to a 16yo patient; A spontaneous report  was received from a healthcare professional concerning a 16 year old unknown gender patient who received Moderna's COVID-19 vaccine (mRNA-1273) mistakenly at 16 year old.  The patient's medical history was not provided.  No relevant concomitant medication was reported.  On an unspecified date, the patient was administered a dose of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection.  The patient was 16 years old at the time of administration of the vaccine.  No treatment information was provided.  Action taken with the mRNA-1273 was not reported.  The event, "vaccine is mistakenly administered to a 16yo patient", was considered resolved on an unspecified date.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
Had seizure on 7/29/07 - unresponsive, no loss of tone, stiffening upper arms, eyes deviated to left lasted about 1 min, no post-ictal symptoms. Seizure free since 1/2001.
Skin lesion on right upper extremity; Possible contact transmission of smallpox; This case was obtained on 22APR2021 from the review of scientific literature.    A 27-year-old female presented to health clinic with a 7-day lesion on her right upper extremity. She disclosed that her boyfriend was a marine and was vaccinated against smallpox two weeks prior to her developing the skin lesion. The specific smallpox vaccine that he received is unknown and her boyfriend did not cover the vaccine site as instructed. The patient's skin lesion was non-itchy, approximately 5 millimeter (mm) blister like rash that ulcerated with a grayish, white center and had a surrounding red border. She denied any fever, chills, pets at home, insect bites or trauma to the area. While at the health clinic, the patient's skin lesion was unroofed, and a sample was sent to Laboratory of Public Health for identification. The sample returned positive for Orthopoxvirus DNA by polymerase chain reaction (PCR). The patient was instructed to cover the area while at work, keep the lesion open to air at home, and to avoid skin-to-skin contact. The clinic also reported the event to Department of Health for possible contact transmission of smallpox. The outcomes of the events of possible contact transmission of smallpox and lesion on her right upper extremity was not reported.  The patient's medical history includes asthma. Concomitant medications include unspecified nebulizers for asthma.  Author's Comment: Recipients of smallpox vaccine have a potential for autoinoculation and inoculation of close contacts. Hence, the vaccine recipients should be well educated about proper care of the vaccination site for preventing possible contact transmission of the virus. These include covering the vaccination site, proper hand washing after bandage changes, and avoiding skin-to-skin contact.  Company Comment: The suspected drug as described, was possible ACAM2000. ACAM2000 is a live vaccinia virus that can be transmitted to persons who have close contact with the vaccinee. In this case, the female presented a lesion that was confirmed to be Orthopoxvirus. The lesion is consistent with a contamination due to a secondary transmission from the male who was recently vaccinated; therefore, the lesions are considered related to ACAM2000.  The case is an adverse event of special interest (AESI) and considered medically important for the purpose of submission to the FDA as required commitment.; Sender's Comments: The suspected drug as described, was possible ACAM2000. ACAM2000 is a live vaccinia virus that can be transmitted to persons who have close contact with the vaccinee. In this case, the female presented a lesion that was confirmed to be Orthopoxvirus. The lesion is consistent with a contamination due to a secondary transmission from the male who was recently vaccinated; therefore, the lesions are considered related to ACAM2000.  The case is an adverse event of special interest (AESI) and considered medically important for the purpose of submission to the FDA as required commitment.
Facility manager reported patient presenting with hypertension per the EMS when they were taking her to the hospital.  No reported symptoms prior to Friday.  Retirement home was informed that patient had a stroke on Friday.
Returned to nurse about 8 minutes after receiving injection, c/o tongue feeling "tingling" and thick.  Given 0.3cc epinephrine at injection site, 0.2cc in right deltoid.  Declined to call EMTs.  No further progression of symptoms.  Called personal physician.  Went home to take Benadryl and rest.
Explained to Pediatrician she'd had a fever all week and had one at time of shots, she checked her out and said it was due to teething and administered the shots anyway. They were given in her legs, not sure which one went into which leg. Her fever went over 103 that evening, I gave her Tylenol. She slept well. The next morning at 9 she awoke having a seizure. Paramedics said it was most likely a febrile seizure until 6 days later she had another seizure, less severe, that was not accompanied by a fever. She was admitted to the hospital and tests were run, all coming back negative. Per follow up report received on 05/16/2005: Patient has a few more appointments to got to.  She hasn't had any more seizures since the report was filed.  Patient awoke on 05/05/2005 with a seizure.  Going to Pediatrician tomorrown and the neurologitst on the 17th. Per the follow up report-seizures she continues to have to be on Phenobarb to control the seizures. She's still not allowed to receive these injections, not sure what side effect they could cause.
Pt reported that she began to experience hives one week after vaccination, she had no previous reaction to first shot in the vaccination series. Pt's hives began to get gradually worse over the weekend, but as of Monday 4/26/21 the hives seem to be slightly improving or staying about the same. Pt is not experiencing any difficulty breathing.
Received the flu shot on Wed, 11/27. Started to feel achy on Sun, 12/1. Felt progressively worse (achy) on Mon, 12/2. Mon night threw up and from Mon thru Wed evening, 12/4 had chills, fever, dizziness. Started to feel better on Thur, 12/5, but had a headache from Thur - Sat, 12/8. Took Tylenol (capsules) during this entire time and drank 16 oz of water on avg. every few hours to hydrate. Started taking probiotics on Sat, 12/8 because food (toast) wouldn't digest well.
Had a fever, and mild body aches, headache and tired. Last about 24 hours. Took Tylenol for fever
Morning of June 16, 2021, I began feeling pain in right abdomen and had a low-grade fever. By that evening, the pain was excruciating (9/10) and had a fever of 101. That night I went to the emergency room. The doctor assumed appendicitis and ordered a CT scan. The results showed no abnormalities. He ordered a future ultrasound to look for a ruptured ovarian cyst. Ultrasound showed that my reproductive system was "unremarkable" and showed no signs of a ruptured ovarian cyst or any other explanation for the pain. Three days later (06/19/2021) I started my menstrual cycle on schedule. It lasted the normal 6 days and had no unordinary pains. On July 17, 2021, I had my next menstrual cycle on schedule but it was extremely light and only lasted 2 days. Pain was unordinary. Negative pregnancy test. On August 9, 2021 I started my next menstrual cycle but it was 5 days early and extremely heavy resulting in more than usual pain and lasted 10 days. I have no prior history of abnormal menstrual cycles or reproductive complications/concerns.
10/22/08: Vaccination given (see #10 & 13). Noted on recording that interval was in advance of manufacturer recommended 2 years (last 10/10/07). Subject informed and telephone call to Physicians office in reference to matter, with subject present for physician opinion on the matter. 11/03/08: Subject attend routine physical exam w/ stress test conducted at physicians office. 11/03/08: Telephonic conversation subject remarks to feeling fatigue, night sweat, headache, makes relation to vaccination. 11/06/08: Telephonic conversation subject states prior reported sx were persisting not improving, and again remarked attributing sx to immunization. An appointment secured with physician for evaluation of symptoms. 11/07/08: Telephonic conversation subject continues to remark feeling fatigue, night sweat, headache, makes relation to vaccination. Consult physicians, on this date, for evaluation of symptoms and consideration of vaccine (or vaccination in advance of 2 year interval). Lab studies performed. 11/19/08: Subject consulted Infectious Disease Associates: impression: resolving from CMV- no long term damage from early typhoid. 11/20/08: Subject filed form CA-1, for disability benefit for employees under the Federal Employees; Compensation ACt. Subject stated as cause of injury: "after receiving an extra dose of TYPHIM Vi, apparently erroneously from the health services unit, I began to feel ill. I was later diagnosed with CMV- an infectious disease. The disease or virus caused elevated liver enzyme levels. I remain infectious. 11/21/08: Subject consulted Dr "Pt is under my medical care for acute CMV infxn (sic). It is expected that he will make a complete recovery."
First 2 days of vaccine I was achy and fatigued.  3rd day I started having anxiety and weak spells. 4th day extreme fatigue along with shakiness, dizziness, brain fog, and feeling like going to pass out.  Will have to sit or lay down to prevent passing out. This has continued until now.   I will have some blocks of time where I don?t feel this way and will start thinking it?s clearing up. Then it will hit me again.
patient had slight asthma the afternoon of injection, then the morning after she had a swollen arm down to the elbow. Her heartrate increased to 130bpm and she had 99F fever. She went to the ER where they gave benadryl and fluids
Information has been received from a registered nurse (RN) concerning a 7-month-old female who on 15-DEC-2006 and 16-MAY-2007 was vaccinated PO with the first and second dose, respectively, of Rotateq. Unspecified medical attention was sought. No problems were reported. Additional information has been requested.
Patient called inquiring about a rash on her arm. I asked her to come in so that I could look at it. It was a warm, red rash about the size of a softball approximately 4 inches below the injection site. Patient stated that the injection site did not hurt but the rash was tender. The patient also stated that the rash had been getting larger every day. I observed the rash about 2 days after it appeared and informed patient that if it got worse or didn't clear up in 2 days, to contact her primary care doctor. The patient has not contacted us since that time.
mom states pt started to cry 1 hr p/vax & cried for 3-4 days
Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  28 doses of vaccine were administered on 18OCT2021 after being stored in a refrigerator for 33 days. 2 of these were first doses, 5 second doses, and 21 third doses for immunocompromised individuals.
Headache, joint pain, throat hurt, chills, and fatigue for 2 days.
Swelling of legs and upper legs (she has to wear TED Hoses) Fatigue Coughs when laying down or when she is run down or tired
This is a spontaneous report from a contactable nurse (patient). A 65-year-old female patient received PREVNAR 13 via unspecified route of administration on 07Jan2019 at 0.5 ml, single (arm left) for immunization. Patient medical history and concomitant medications were not reported. It was reported that the patient got vaccinated with PREVNAR on Monday 07Jan2019. Since the injection, she has had a great deal of left deltoid pain (the worst pain she has ever had after any injection) that it was her whole left arm not just in the injection site, sleep disturbances (she can't sleep and then the next day and sleeps all day into late morning), very irritable, stomach issues (diarrhea, abdominal pain and some nausea); she says she went in perfectly healthy and Tuesday woke up with a heavy feeling in her chest (felt it on the first day it has but has subsided to some degree); feeling like a different person; she mentions tiredness and feeling fatigue. The patient also reported that today, she noticed tiny red dots (rash) on her left arm. Outcome of the event "woke up with a heavy feeling in her chest (felt it on the first day it has but has subsided to some degree)" was recovering. Outcome of other events was unknown.
Reports 2 days after vaccine given, arm very sore radiating to shoulder, swollen lymph node above clavicle, not resolved, very painful.