chrisvoncsefalvay/vaers-outcomes huggingface dataset:
achy; tired; Initial information was received on 14-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves an 80-year-old female patient who had achy (pain) and tired (fatigue), after receiving INFLUENZA VACCINE and MODERNA COVID-19 VACCINE.  The patient's past medical history included feeling abnormal. The patient reported that she had not been feeling good.  At the time of the event, the patient had ongoing secondary pulmonary arterial hypertension.  It was unknown if the patient had any additional medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included WARFARIN SODIUM.  On 22-Sep-2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date in March and April, the patient received a dose of suspect MODERNA COVID-19 VACCINE not produced by Sanofi Pasteur (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious achy (pain) and tired (fatigue) (unknown latency) following the administration of INFLUENZA VACCINE and MODERNA COVID-19 VACCINE.  It was reported "On an unreported date, the patient experienced events of achy (pain) and tired (fatigue). Co-suspect included Moderna COVID vaccine (elasomeran) and Flu shot (influenza vaccine). The patient reported that she had not been feeling good (feeing abnormal previously reported). She received the Moderna COVID vaccine in March and April and the Flu shot on 22 Sep 2021."  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for both the events.  There will be no information available on the lot number for this case.
had napped 2-3 different times, which was unusual for her daughter.; Her daughter immediately had right arm injection site pain; Her daughter was really tired for 24-36 hours afterwards/Her daughter was really exhausted for 24-36 hours afterwards; This is a spontaneous report from a contactable Nurse. This Nurse (patient's mother) reported for a 13-year-old female patient (reporter's daughter) that: A 13-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0168), via an unspecified route of administration, administered in Arm Right on 24Jun2021 at 13:21 (at the age of 13 year) as single dose for covid-19 immunisation. Medical history included ongoing heart disease congenital diagnosed prior birth, ongoing irregular heart rhythm. Patien''s family history includes her daughter's grandmother (patient's mother's mother) & her daughter's aunt (patient's mother's sister) all have holes in their hearts & they all have implantable defibrillators. History of all previous immunization with the Pfizer vaccine considered as suspect reported as none. Patient not received additional vaccines on same date of the Pfizer Suspect. Patient was not received any other vaccine four weeks prior vaccination. She stated her daughter (patient) didn't have an implanted defibrillator at this time & her daughter's doctor was waiting until her daughter was older. She reported her daughter's irregular heart rhythm had a genetic component, but she did not know if the irregular heart rhythm was related to her daughter's congenital heart disease. Patient's mother reported her daughter received her first COVID-19 Vaccine dose on 24Jun2021 at 01:21PM in her right arm, and immediately had right arm injection site pain on 24Jun2021. She said her daughter, was really tired and exhausted for 24-36 hours afterwards on unknown date in Jun2021. She said she was not sure if her daughter tiredness and exhaustion started on 24Jun2021, but her daughter took a nap that evening (24Jun2021), and on the next day (25Jun2021) had napped 2-3 different times, which was unusual for her daughter. She reported she offered her daughter Ibuprofen and an ice pack for her right arm injection site pain, and her daughter refused. Patient not visited to physician office or emergency room for the events. The outcome of the events her daughter was really tired for 24-36 hours afterwards/Her daughter was really exhausted for 24-36 hours afterwards was not recovered and had napped 2-3 different times, which was unusual for her daughter, her daughter immediately had right arm injection site pain was unknown.  No follow-up attempts are possible. No further information is expected.
Information has been received from a pharmacist referring to a 15 year old female patient. The patient's medical history included juvenile rheumatoid arthritis (RA). On an unknown date and on 18-SEP-2015 ("10 days ago") the patient was vaccinated with her first and second dose of GARDASIL or GARDASIL 9 respectively. Pharmacist did not know if the vaccine injections were GARDASIL or GARDASIL 9. It was reported that the patient had experienced pain at the injection site, after the first dose of vaccination, on an unspecified date. Pharmacist reported that patient's mother informed her that the patient experienced redness, "significant swelling", pain and a raised area, "similar to the bubble formed with a para-phenylenediamine (PPD)" at the injection site, immediately after the second dose of vaccination. Pharmacist reported she was informed by patient's mother that the patient did not believe the second injection was administered the same way, as the first injection. Patient sought medical attention by calling pharmacist. No treatment was given for events. The outcome of all the events was reported as not recovered/not resolved. The causality was not reported. Additional information has been requested.
TESTED + FOR COVID ON    1-18-22 AT  HOSPITAL    ; AGAIN ON   2-10-22     AT       HOSPITAL                            . DECEASED 2-24-22.
Hives - started 10-17 about 6 of them and lasted one week.
The patient said that their arm was sore after getting the vaccine on the 16th and the soreness has got worse instead of better as of the 20th.  He said the soreness radiates from his deltoid to his thumb on that arm.  The pain gets better with the administration of ibuprofen.
Patient experienced myalgia,headache, and fever for 2 days after receiving vaccine. The adverse events did improve on their own. Patient did not need medical attention. Patient took tylenol for their headache.
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: patient received injection, after a bit of time it swelled at site of injection . patient stated it was slightly sore and said his first two  vaccinations did not elicit this reaction . we will follow up with patient .
Received her first vaccine and then contracted with Covid 19; A spontaneous report was received from a consumer concerning a female patient of an unknown age who received first dose of Moderna's COVID-19 vaccine (mRNA-1273) and contracted with COVID-19.      The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, after receiving first vaccine and the patient contracted with COVID-19. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event contracted with COVID-19 was not reported.; Sender's Comments: COVID-19 in this patient is unlikely to be due to the Moderna COVID-19 vaccine
At site of injection: swollen, red, pain, soreness, Overall feeling of tiredness and feeling blah, loss of appetite, mild headache, pain radiating down length of injected arm, low grade fever.
Approximately 45 seconds after  vaccination, patient began drooling and became diaphoretic, pale, and non-responsive, although she remained conscious. The patient's mother thought patient looked "blue." A Health Department nurse administered one EpiPen while another staff member called 911. Patient stopped drooling, regained normal color in her face, and began smiling almost immediately  after epinephrine was administered. Nurse then took and recorded patient's blood pressure as 92/62, pulse as 64bpm, and respiratory rate as 24. Paramedics arrived approximately five minutes later and evaluated patient, who seemed to have returned to normal. Patient and her mother declined to have the patient transported to the hospital via ambulance for further observation. Patient was then driven home by her mother. Deputy COVID Operations Chief spoke with patient's mother over the phone around 6:30PM that same day to follow up with the patient. Patient's mother reported that the patient had returned to her normal self, had not experienced any further adverse events, and wished to move on from the incident.
Side effects were low grade fever, chills, body aches, headache.  Lasted 24 hours
CHILD CRIED FOR MORE THAN 30 MINUTES BUT LESS THAN TWO HOURS AFTER THE SHOTS. ONE HOUR AFTER INJECTIONS CHILD DEVELOPED FEVER, 100.1 F, WAS RESTLESS, IRRITABLE AND LOST APPETITE. SEEN IN THE ER; NO ABNORMALITIES WERE FOUND. ONE WEEK LATER, CHILD WAS ADMITTED TO THE HOSPITAL WITH HISTORY OF LOSS OF APPETITE, IRRITABILITY, REFUSED EVEN BEING NURSED, PERIODS OF AGITATION. AS PER PARENTS NOT A DEFINITIVE DIAGNOSIS WAS ESTABLISHED. 3 DAYS LATER WAS DISCHARGED, STILL WITH THE SYMPTOMS BUT LESSER. (PENDING TO GET SUMMARY DISCHARGE NOTES) Follow-up: After a thorough search of our files, we have no record of this patient ever being seen at this facility in the last 10 years. Hospital's retention policy is for a period of the last 10 years. Medical records that are 11 years or older have been destroyed.
broke out into hives all over body; This case was reported by a pharmacist via call center representative and described the occurrence of hives in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient broke out into hives all over body. After few days, the patient recovered from hives but he was worried about receiving 2nd dose of Shingrix due to allergy concern.
Severe swelling, tightness and pain of left upper limb; erythema of forearm with spread to arm.  Extreme pain to light touch. Took Benadryl.  Called physician and informed to not take flu shot again.
I ran a fever for 48 hrs. At around 101 degreesI expected that. What I?m reporting is that my menstrual cycle has been significantly affected since receiving my vaccine. Before my entire cycle would last 4-6 days at the most. Now I will spot and pass a lot of clots for a week and then heavily bleed for several days. I?m on my third menstrual cycle post vaccination and it has gotten any better and only gotten worse. Before I would say I was average on my heavy days going through 3-4 pads I a day. I?m currently going through (bleeding through) 10-12 pads a day going on 7 days currently. My friend and I got our vaccines together and she is having very similar issues as well.
This case was reported by a physical therapist, who was also the pt. The report described the occurrence of suspected Lyme disease in a 35 year old female who participated in a lyme disease vaccine clinical trial. It was subsequently confirmed that the pt received Lymerix disease vaccine (study vaccine 215274). According to the pt's report, she received the third dose of study vaccine on an unspecified date in 1992. On an unspecified date in 2004, the pt began to experience signs and symptoms of Lyme disease, specifically weakness and fatigue. The events persisted as of 29Apr04. Review of clinical trial records revealed the following information. At the time of study enrollment on 16Feb95, the pt reported no relevant medical history of concurrent conditions. Concurrent medications included Levonorgestrel + ethinyl estradiol (Triphasil) for contraception. On 16Feb95, the pt received the first dose of Lyme disease vaccine IM in the left deltoid muscle. Later that day, at an unspecified time post immunization, she developed an injection site reaction characterized by soreness and slight swelling. The injection site reaction resolved without treatment on 18Feb95. It was recorded in the clinical trial documents as mild severity and related to study vaccine administration. On 12Mar95, the pt developed an ear infection, which was treated with ciprofloxacin and resolved on 17Mar95. This event was recorded in the clinical trial documents as mild in severity and unrelated to study vaccine administration. The injection site reaction and ear infection were reported to the IND and therefore, are not listed as adverse events in this report. On 15Mar95, while still receiving ciprofloxacin therapy for the treatment of an ear infection, the pt received the second dose of Lyme disease vaccine IM in the left deltoid muscle. Later that day, at an unspecified time post immunization, she experienced soreness at the injection site and achiness in her left arm. The events were treated with ibuprofen and resolved on 22Mar95. They were recorded in the clinical trial documents as mild in severity and related to study vaccine admin. These events were reported to the IND and, therefore, are not listed as adverse events in this report. On 10Apr96, the pt received the third dose of Lyme disease vaccine IM in the left deltoid. No adverse experiences were recorded in the clinical trial documents following this dose of vaccine. The pt's last study visit occurred on 19Oct96.
9/16/21  Mass of lower outer quadrant of left breast---breast cancer 51 year old female presenting to the clinic for a well woman exam including a pap.She denies any previous abnormal pap smears. She had a mammogram done on 7-06-21 and it was read as normal.  The patient states that she noticed a lump in her left breast about three weeks ago and it is quite large. She had her Covid vaccines in April. She has diabetes and hyperlipidemia. She was recently started on Crestor and had Januvia added to her DM medications. She has no concerns with these medications. The patient does not have any other concerns.  10/28/21:   51yr old female referred for evaluation of recently diagnosed carcinoma of the left breast.  This was first noted as a palpable mass by the patient in Sept.  Previous screening mammogram in July was negative.  Follow-up mammogram showed in the area of palpable mass located at roughly the 3:00 position, an increase in the amount of density in the lateral aspect of the left breast but a well-defined mass was not identified. Ultrasound showed in the area of clinical concern at 3:00 o'clock, 6 cm from the nipple a lobulated hypoechoic mass that measures 21 x 15 x 30.9 mm. No abnormal left axillary lymph nodes were identified.  A ultrasound guided biopsy was performed on the left breast mass with pathology revealing infiltrating ductal carcinoma of the breast.  11/9/21 initiated therapy with oncologist.   Currently receiving chemotherapy.
Patient received Zostavax Vaccine on 4-29-09 and had been warned about the localized red itchy welt that could occur at the injection sight and it did appear 24 hours after the injection.  Then patient called pharmacy on 5-4-09 and said besides the welt at the injection sight, she had a red itching rash appear on 5-2-09 vaginally.  The patient has had a history of UTI's and had a course of Doxycycline 100mg on 3-23-09 and Nitrofurantoin BID 100mg 3-4-09 & 2-25-09.  I advised the patient to contact her physician & make an appt. for further evaluation
I received my first dose vaccine in my left arm. The following morning my right arm from the elbow all the way down was completely numb and I had lost the grip strength and function of about 50%. And to this date I have not got all the feeling back actually I have not got most of the feeling back and I have only gotten back about a total of 75% of my grip strength and function
Resident initially started with some tongue swelling and feeling short of breath.  Benadryl was administered, the resident continued with tongue swelling, chest pain and back pain.  Tongues was noted a twice the size of normal.  The resident has tremors from parkinsons disease that were also exacerbated.
Swelling, warm at injection site. Left deltoid. Given BENADRYL and Ibuprofen.
Developed hives  & rash. Use Hydrocortisone 1% cream & symptoms got better!
A few hours after injection. Bleeding, pain and bruising at injection site that has persisted at least 3 weeks. No treatment.
Received Varicella shot on 4/22/03. On 4/24 developed fever 102, HA, Lt arm soreness,body aches and 2 areas of redness and itching on leg. Dr told employee to use benadryl,tylenol and ice to arm prn.
I got my shot at my work and both shots I felt ill but the second one was very bad, I was ill for about a week.  When I started getting better I began breaking out in a rash on my arms, legs, back and chest areas. My skin was hyper sensitive like I had a sever sun burn off and on for weeks. I had cold sores in my mouth almost continuously for weeks .  The chest cleared but the back, arms, and legs did not.  I did a small burst of prednisone 30, 20, 10 and it got better then came back.  My doctor had me do a logger one with 40 mg and then tapering down.  This larger dose was done in March and helped "reset" my immune system
COVID-19 Test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 Test) 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 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced COVID-19 (COVID-19 Test). At the time of the report, COVID-19 (COVID-19 Test) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Pecived 2ND gardasil tue. jan 29th. Started having abd. pain that Night. Pain Sharp and Radiated into Back. Patient called 2-1-08 at 430 pm to Ask if related to shot. No Nausea; No vomiting. No Fever. Pain gone by Am 2-2-08. was instructed to go to ER if symptoms got worse.
This case was reported by a physician via call center representative and described the occurrence of general body pain in a adult female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of pain (1st dose, refer case US2018130236). On 18th July 2018, the patient received the 2nd dose of SHINGRIX. On 18th July 2018, less than a day after receiving SHINGRIX, the patient experienced general body pain and fever. On 19th July 2018, the patient experienced injection site itching, injection site induration, injection site tenderness and injection site erythema. On an unknown date, the outcome of the general body pain, injection site itching, injection site induration, injection site tenderness, fever and injection site erythema were not recovered/not resolved. It was unknown if the reporter considered the general body pain, injection site itching, injection site induration, injection site tenderness, fever and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but it could be 58 or 59 years of age. The patient experienced body aches, fever, and injection site reactions including red, hard starburst 2 to 3 inches in size, tender and itchy. On 19th July 2018, 1 day after receiving SHINGRIX, the patient experienced injection site reactions.
Inflamed swollen area; Funny taste in mouth; 102.7 fever 2 days; Swollen sore lymph nodes under arm; Swollen red rash on arm; Redness started at injection site little below shoulder and has spread to elbow; sore to touch; itchy; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 30Mar2021 at 13:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and asthma. The patient had history of allergy to cheyenne pepper, almonds, pomegranate seasonal allergies. Concomitant medications included metformin (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA) and fluticasone propionate (FLONASE), all from unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 09Mar2021 at 12:00 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 at 08:30, the patient experienced 102.7 fever 2 days, swollen sore lymph nodes under arm, swollen red rash on arm. Redness started at injection site (little below shoulder) and since Tuesday had spread too elbow. The inflamed swollen area was warm, sore to touch, and itchy. A funny taste in mouth. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events and included treatment with ice area and ibuprofen (MOTRIN). The clinical outcomes of 102.7 fever 2 days, swollen sore lymph nodes, swollen red rash, redness at injection site, inflamed swollen area was warm, sore to touch, and itchy, funny taste in mouth were not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Headache - onset Friday night until today 11/23/09, associated photophobia, and nausea/vommiting X2 this morning upon waking at 5:30am Fever - 100.2 today in the clinic, patient unsure of onset.  Abdominal pain - Onset 11/23/09 morning, 2x loose stool and N/V Fatigue - onset 11/20/09 evening, still present.
Within ~5-7 minutes of receiving the first dose of the pfizer vaccine in my right shoulder, I started to feel lightheaded/dizzy and disoriented. Heart rate increased a bit. Slightly labored breathing. Started feeling overall strange throughout body, general malaise. Didn't advance beyond this. Took 50mg of benadryl shortly after and symptoms improved over the following hour.