chrisvoncsefalvay/vaers-outcomes huggingface dataset:
aches and pains; slight fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10Mar2021 (Lot number: EN6205, Expiration Date: 30Jun2021) at the age of 72 years as dose 1, 0.3 ml single and administered in arm right, administration date 17Feb2021 (Lot number: EL9266, Expiration Date: 31May2021) as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Other than she takes injections with Enbrel every couple of weeks for her Rheumatoid Arthritis. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "aches and pains"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "slight fever". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts completed. No further information expected.
Allergic skin reaction; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (Allergic skin reaction) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DERMATITIS ALLERGIC (Allergic skin reaction) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). At the time of the report, DERMATITIS ALLERGIC (Allergic skin reaction) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that patient had never been allergic to anything.
HORRIBLY STIMULATED. As if given narcotics and strong stimulants. Cries for hours, cannot sleep. This is the same as what we experienced after her two-month vaccines. It is delayed and begins a few days afterwards. Child is in a state of complete unrest. Not normal irritability or restlessness -- extreme, animal-like.
Varicella vaccine administered in (R) upper arm subcutaneously on Monday, 03/25/13. On 03/26/13, Pt said she woke up and noted a small pimple at site of injection. Patient said reaction continued to grow. Patient came into clinic on 03/28/13 area with erythema, edema 11cm x 13cm. Patient c/o itching at site and pain with movement. Patient treated for cellulitis at injection site. Doctor prescribed BACTRIM x 10 days.
After injection she started experiencing a burning pain in arm which continued after leaving facility. States that pain was significant enough to have to use ice and NSAIDs. Next day still having significant pain and 1 syncopal episode- she felt clammy and warm and then sat down and lost consciousness. She is not sure how long she was not conscious.
This spontaneous report as received from medical assistant refers to multiple unspecified patients of unknown age and gender. Information on pertinent medical history and concurrent condition was not provided. On an unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # N004799, expiry 15-NOV-2019 (dose and route not reported) for prophylaxis. It was reported that on unspecified dates, the vaccine was exposed to a temperature between 2 Centigrade degrees and 8 Centigrade degrees (1.8C) for 42 minutes. There was previous temperature excursion between 0 Centigrade degrees and 1 Centigrade degree for 1 hour and 56 minutes and another excursion between 9 and 25 Centigrade degrees (11.4C) for 1 hour and 41 minutes. The call was placed because of a Digital Data logger report. No adverse effects reported. As of 01-SEP-2017, all telephone attempts to obtain follow up information had been unsuccessful. Follow up information has been received from the medical assistant on 05-SEP-2017. The patient's age was confirmed as 11 years. It was also confirmed that on 18-JUL-2017 the patient was vaccinated with the improperly stored GARDASIL 9 lot # M044717 (previously reported as lot # N004799). This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA005737: US-009507513-1709USA005738: US-009507513-1709USA005747: US-009507513-1709USA005740: US-009507513-1709USA005741: US-009507513-1709USA005742: US-009507513-1708USA001768: US-009507513-1709USA005744: US-009507513-1709USA005745: US-009507513-1709USA005746: US-009507513-1709USA005736: US-009507513-1709USA005735: US-009507513-1709USA005748: US-009507513-1709USA005739:
Confirmed COVID-19 diagnosis; Confirmed COVID-19 diagnosis; Erectile dysfunction; heart palpitations; flu-like symptoms; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot numbers and expiry dates not reported), via unspecified routes of administration, in the arm on unspecified dates, as dose 1, single and dose 2, single both for COVID-19 immunization. Medical history included autoimmune issues. The patient's concomitant medications were not reported. The patient experienced confirmed COVID-19 diagnosis on 04Oct2021. Also, patient experienced heart palpitations leading to ED and echos following the vaccinations on unspecified dates. Patient also experienced flu-like symptoms for weeks after vaccination. Antibody tests following the vaccinations were in the 800s. Patient also experienced magnetism at the shot site on the first arm and the entire length of the arm for the second shot arm. The magnetism persisted. Patient was about to receive REGENERON (at the time of report). The outcome of the events was unknown.  Information on lot/batch number will be requested during follow up.
Severe dizzyness and vomiting the first day. 3/12/2021  Then reoccured 3 more days spread out over the next 2-3 weeks.  Last episode of dizzyness occured April 8th 2021.
Local irritation to injection site. Mild redness visible. BENADRYL gel applied topically. Redness diminished within 15 minutes. No further treatment required. Follow up the next day as per patient. No further reaction noted and reported to work.
Local reaction- Unable to walk that day. Was crawling. Only large swelling 3 inches x 3 inches tenderness with red border. Left thigh
Severe systemic inflammatory response syndrome starting within 24 hours of vaccine dose characterized by fever, malaise, abdominal pain, chills, "cold sweats" with nausea and vomiting. NOTE: Patient had never received Heplisav-B before (was vaccine naive to this).
Pt had MMR/HIB/TB tine test on 28SEP91; On 3OCT91 Thursday; pt started w/runny nose, swollen glands & puffy eye; On 5OCT91, Saturday fever went to 102; On 6OCT91 mom noted red spots on legs & 7OCT91 seen by MD fever 102.2 ax & red papulas;
About 1 hour and 15 minutes after receiving the vaccine I became dizzy.  3 1/5 hours later I developed chills which lastly briefly. The next day I had  huge area on my  left eye on my pupil which lasted for 5 days. I have blue eyes and right at toward the end of the blue I have white deposits.  On  2/24/2021 I went  see an eye doctor Dr. He diagnosed me with "whiss" ring around both of my eyes, and seen spot on my lenses on my left eye.  I started starburst with my left eye, this did not develop until after I received the vaccine.  I have a dot on my right eye now. On 02/26/2021 see another eye doctor Dr., he also said I have deposits around my cornea, acknowledged the starburst effect on the left eye, and noticed the "whiss" ring.  Since I took the vaccine my eyes have become very light sensitive.  The doctors have told me this conditions are permanent, if it gets worse they will have to scrape the eye and have a laser surgery.  I do  not remember when it started but it 2inches by 3 inches, red patch which started at the injection site and went diagonal.
Information has been received from a registered nurse concerning her 34 year old daughter who has an allergy to penicillin and a history of varicella as a child in both grade school and high school, each a mild case. The patient is currently taking "birth control pills." On approximately 20AUG2003, the patient's daughter was vaccinated with a dose of varicella virus vaccine live. Subsequently, on 05SEP2003, the patient experienced three lesions at the waist line and pain from her back to neck. She was diagnosed with shingles and treated with tylenol and acyclovir, Zovirax, cream and tablets. On 08SEP2003, the patient developed an additional lesion her her finger. a specimen was obtained. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information was received from a physician's office which indicated that the patient did not receive varicella virus vaccine live herself, her daughter did. The patient thought that she contracted shingles from the child afterwards, however , a herpes viral culture on 05SEP2003 was negative for herpes simplex. It was noted that there was "no adverse reaction from the vaccine." The reporter also indicated that her grand daughter, the patient's daughter, developed an adverse experience after being vaccinated with a dose of varicella virus vaccine. No further information is expected.
Mother called and stated pt had a fever, diarrhea and rash for 9 days.  When taken to the MD, was told the rash looked like diaper rash as it was only on the diaper area. Pt had a temp of 100.3.  Child referred to PMD.
Patient reported a pain level of 10/10 within 24 hours of receiving the vaccination.  Patient also reported a lack of full range of motion in the left arm where the vaccine was administered.  Patient allowed 7 days for the symptoms to dissipate with no relief at which point she seeked medical attention and received an xray. Extensive details of that X-ray were not shared.
UTI; A spontaneous report was received from a consumer (Unknown age and gender) who received Moderna's COVID-19 vaccine and experienced urinary tract infection (UTI).  The patient's medical history was not provided. No relevant concomitant medications were reported.   In Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On Unknown date, she experienced Urinary tract infection. Treatment: HCP provided antibiotics.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome for the event UTI is Unknown.; Reporter's Comments: This case concerns a patient, who experienced a serious unexpected event of urinary tract infection. The event of urinary tract infection occurred  on an unspecified date after first dose of mRNA-1273, lot # unknown.  Treatment included antibiotics (not specified). Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
I received second Moderna dose on 6/06/2021 at 1:00 pm. At 2:00 am I woke up with fever, chills and full body aches. I feel like I have the flu with no energy.
Chills, diarrhea starting around 3pm 48 hours after shot.  Arm started to swell at that point and because very red and hot.  Followed by fever and aches that lasted into the next day.
Twelve hour swelling right side of face (right parotid gland) with slight erythema. No fever. No other abnormality. Recovered symptomatically.
Rednees pain and swelling at the injection site, 10 days after the shot.
Information has been received from a physician concerning an 8 year old male who on 6/27/96 was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that on 7/1/03 the patient developed a mild case of chicken pox with about 75 lesions. The patient was sick for about three or four days and subsequently recovered. Unspecified medical attention was sought. A product quality complaint was not involved. No further information is available.
I got a severe stomach flu and joint elbow pain and went behind my knee, lesions started on lower leg with red bumps and went across ankles and feet but still experiencing lesions which are extremely painful, feet are swollen and tingling and numbness of pain. I've been to ER and had an EKG and ultrasound performed.
Approximately one hour after administration broke out in hives/rash around neck, body and legs. Treated with over the counter BENADRYL.
Extreme headache shortly after, treated with water and Advil, no big deal.  Woke up in the middle of the night with a horrible fever, headache, rash, and chest pains. Treated with nothing, and it eventually went away this morning, considered going to hospital.
Chills, violent shaking, followed by shooting pains in several joints. Chills lasted two hours. Joint pains lasted about four hours. This morning, 9/27/2015, weakness & fatigue were pronounced for about six hours.
This spontaneous report as received from a 63 years old female patient refers to herself. The patient's pertinent medical history was high blood pressure. The patient had allergy to iodine and tetnas. The patient was vaccinated subcutaneously with ZOSTAVAX (1 time vaccine, dose and lot # were unknown) on 19-OCT-2012 (reported to prevent pregnancy). No other co-suspects were reported. Concomitant medications included blood pressure medication and cholesterol medication. On 20-OCT-2012 the patient stated she had a red area about the size of a baseball on her arm where the vaccine was administered. She also stated it was itching. No treatment was given for adverse event. At the report time the outcome of event was unknown. The patient did not sought medical attention. No lab diagnosis studies performed. Additional information is not expected.
Patient began having itching and throat irritation  which advanced to abdominal pain and headache.
I developed a productive cough (had a dry cough before that) after the first Moderna dose.  Within a few days after the second dose four weeks later, I began coughing up green phlegm.  Less than two weeks after the second dose, I developed a fever.  If I were the only one who experienced lung issues after the vaccine, I would not be reporting this.  However, I've talked to four others about their experiences and three report lung inflammation, one even reported getting pneumonia, after getting vaccinated.  I do not know if they all received Moderna, however.  None had received the J&J vaccine.
Facial swelling and hives, 2 hrs after administration of vaccines. Rash (urticaria) progressed to extremities in next hr. Benadryl 12.5 mg was given 3 1/2 hrs after administration with gradual improvement. Minimal facial swelling 4 hr after vaccine. Ordered tylenol X1;asymptomatic overnight.
states that a patient received two doses of Fluzone high dose 29 days apart. One on 25-Sep-2020 and one on 23-Oct-2020 with no adverse event; Initial information was received on 26-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 79-year-old male patient received two doses of influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent] 29 days apart. one on 25-sep-2020 and one on 23-oct-2020 (inappropriate schedule of product administration). (formulation, dosing frequency and strength were unknown) (lot number: UJ512AB and expiry date: 30-Jun-2021) at 0.7 ml via intramuscular route in unknown administration site for prophylactic vaccination.  Medical history, past medical treatment, vaccination and family history were not provided.  This was an actual medication error case due to inappropriate schedule of vaccine administered (latency unknown).  At the time of reporting, no adverse event was reported.  Disclaimer: 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 set out in Directive 2001/83/EC and module VI of the Good Pharmacovigilance Practices or construed as an allegation or claim made by the marketing authorization holder that any third. The classification as a medical error is in no way intended, nor should it be interpreted party has contributed to or is to be held liable for the occurrence of this medication error.
Migraine, chills, body aches, fatigue and malaise for the first 48 hours.  Sudden bruise on right calf that had pain only when touched.  From Sunday afternoon until Tuesday morning. shortness of breath at times, cold toes and fingers on right side especially, weakness, trouble concentrating or thinking.  As of Tuesday morning cough and congestion (like a cold), tiredness and weakness but not extreme like day before.  Sore muscles and some edema in legs.
Intermittent pain in upper left shoulder and in heart bitbothdonot occur at same time. This has occurred with all 4 covid vaccinations. Lasting few weeks. Thought I should report it as it has continued with each one received
pt recv vax;noted tricep soreness;T 99 that noc;feeling of severe fatigue;rt arm over tricep was hot, erythematous & edematous;seen by MD & tx w/ atb for possible cellulitis;
45 minutes after taking the first dose of the live oral vaccine,the patient started experiencing malaise, joint pain, dizziness, increased heart rate and a fever of 101 degrees farenheit. The patient stated that she had taken the entire vaccine course about 10 years ago with no adverse reactions. The patient denies illness prior to taking the vaccine. The vaccine regimen was stopped and the patient's symptoms were treated accordingly with over-the-counter medications.
Swollen arm Near the Injection Site; Sore Arm Near the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen arm Near the Injection Site) and VACCINATION SITE PAIN (Sore Arm Near the Injection Site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes mellitus.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swollen arm Near the Injection Site) and VACCINATION SITE PAIN (Sore Arm Near the Injection Site). On 25-Jan-2021, VACCINATION SITE SWELLING (Swollen arm Near the Injection Site) and VACCINATION SITE PAIN (Sore Arm Near the Injection Site) had resolved.            Treatment medication included Tylenol.   This case was linked to US-MODERNATX, INC.-MOD-2021-020539 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-020539:Same patient, 2nd dose
Pt recvd vax 22MAY92 & approx 1 minute following vax pt exp nausea, lost consciousness, foamed @ mouth, had tonic/clonic sz activity & loss of bowel & bladder function; EEG revealed rhythmic sharp theta seen in mid temporal;
Patient was given another series of shingles vaccine even though she had them done previously in 2018 per pharmacy records.
This spontaneous report was received from a nurse refers to multiple unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, patients were vaccinated with improperly stored VARIVAX, Lot # M000760, expiry date 06-JAN-2018 and Lot # M009768, expiry date 23-FEB-2018, subcutaneous, (dose and frequency not reported). No adverse effects were reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
VACCINE WAS MIXED WITH DILUENT FROM A MULTIDOSE VIAL THAT HAD BEEN OPENED AND USED ON A PREVIOUS DAY.  PATIENT HAS NOT HAD ANY COMPLAINTS OF ADVERSE REACTIONS.  NO COURSE OF TREATMENT HAS BEEN REQUIRED.
Vaccine failure: pt exposed to mother with shingles and developed varicella approximately 3 weeks later. Temp 97.3. Multiple vesicles, healing excoriated papules on head/trunk/extremities.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information about the patient's medical history and concurrent conditions was not reported. On 13-AUG-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # K026386, expiration date: 15-DEC-2016 (administration route was not reported). No concomitant therapies were reported. No adverse effects were reported. According to the reporting nurse, the dose was exposed to a temperature excursion from 12-AUG-2015 to 13-AUG-2015, for a total of 17 hours at 5.5 C. This is one of several reports from the same reporter. Additional information has been requested.
Bad headache, chills, fever, body aches, fatigue within 2-5 hours Then, tightening of chest, neck glands swelling and shallow breathing (great difficulty in breathing).  Breathing problem, lasted a short time. This is 3rd day and only symptoms left are body aches and fatigue. Getting better each day.
with this 1st of 2 shots I began getting a headache that began within 1 hour after the shot.  The headache immediately became intense and stayed.  Advil did not do anything for it.  That same evening I began having intense abdominal pain on my right side, it became so bad I was scared my appendix was going to burst.  I had my son on standby to take me to the hospital.  It was so severe I could not stand.  The only way that I can describe the pain would be: after natural birth and you begin nursing, the insanely intense contractions of the uterus to shed the afterbirth is how intense the pain was. I then started my menstrual cycle but was not supposed to for another week and 1/2.  The pain stayed, but did dull some, it wasn't as sharp but still intense.  My flow was extraordinarily heavy and I lost count of how many huge blood clots I passed.  Some clots were the size of my palm.  This cycle lasted a full 7 days.   My normal cycle starts with a little spotting, then 1 or 2 days of medium flow, then a couple days of spotting.  I also do not have my cycle every 30 days, more like 38-40.  I figure its pre-menopause.
Axillary abscess/Abscess in left armpit; This spontaneous case was reported by a consumer and describes the occurrence of SUBCUTANEOUS ABSCESS (Axillary abscess/Abscess in left armpit) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis. Patient had no known allergies. Concurrent medical conditions included Diabetes since 2011, Blood pressure high since 2011 and Psoriatic arthritis. Concomitant products included LOSARTAN, HYDRALAZINE and METOPROLOL for Blood pressure high, METFORMIN for Diabetes, ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol.   In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Dec-2021, the patient experienced SUBCUTANEOUS ABSCESS (Axillary abscess/Abscess in left armpit). At the time of the report, SUBCUTANEOUS ABSCESS (Axillary abscess/Abscess in left armpit) had not resolved. On 20 Dec 2021, the patient experienced abscess in left armpit after covid-19 vaccine. MRNA 1273 was also considered suspect. It was unknown if patient was enrolled in a COVID-19 vaccine trial. No treatment medication was provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.