chrisvoncsefalvay/vaers-outcomes huggingface dataset:
achiness; low grade fever 100.6; fatigue; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL3248), via an unspecified route of administration on the left arm at the age of 55 years, on 09Feb2021 16:30 at a SINGLE DOSE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (IBUPROFEN), colecalciferol (VITAMIN D), vitamin c [ascorbic acid] (VITAMIN C) and Multi Vitamin. The patient had the first dose last 20Jan2021. The patient experienced achiness, low grade fever 100.6 and fatigue on 10Feb2021. The patient underwent lab tests and procedures which included body temperature: 100.6 on 10Feb2021. No treatment was received for the adverse events. The outcome of events was recovered on unspecified date.
his is a spontaneous report from a contactable consumer (patient's wife) via Medical information team. A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 07Apr2021 13:00 (Lot Number: EN6207) as SINGLE DOSE for COVID-19 immunization. Medical history included back pain from an unknown date and unknown if ongoing , COVID-19 from Nov2020 to an unknown date and family history of Amyotrophic lateral sclerosis (ALS) from an unknown date and unknown if ongoing. The patient previously had dose 1 of BNT162B2 (lot number: EN6198) on 17Mar2021 in left arm as single dose for COVID-19 immunization. Concomitant medications included ibuprofen taken for back pain, start and stop date were not reported and probiotics twice a day. The patient had fever that reached 101.5°F on 07Apr2021 and last night when he laid down in his stomach he got nosebleeds on 08Apr2021 until this morning. The patient was given Tylenol and the fever has receded and the nosebleeds have stopped and he can get upward. She is just concerned about the nosebleeds of the patient and she would like to know if this has been reported as a side effect since she was not able to find anything about this. The patient has been having a pretty rough fever of 102 today, which was higher than last time. States that the patient did get a little fever last time but was still able to work. If the patient lays on his stomach, it just drains out and if he lays on his back, he is basically swallowing it.  The patient has been having other symptoms, like aches, pains and 102 fever but is most concerned about the nosebleeds. The patient was feeling feverish last night. States that temperature was 101 or something two hours ago and went checked 15 minutes ago, was 102. States that it has raised in the last couple of hours. The patient just took Tylenol when temperature was 102 as treatment. The nosebleeds started this morning and is still going on now. Drainage is not as much but still has drainage and is now sitting upright. States that when he lays on his stomach, it starts flowing. States that when he came to bed this morning, he suddenly felt like his nose was draining. Explains that he just took another nap on his stomach and found a little blood on the sheets. The patient had no emergency room visit or visit to physician's office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event fever was not recovered and outcome of the rest of events was unknown.
BODY ACHES, CHILLS, SWEATS,FEVER, NAUSEA, VOMITING, DIARREHA FOR 12 HOURS. AFTER THE SYMPTOMS WHERE REDUCED TO BODY ACHES A LITTLE NAUSEA AND HEADACHE. PATIENT ADMINISTED SELF CARE BY INDUCING HOME MADE SALINE SOLUTION, ICE BATH AND DRINKING SUGAR WATER ONLY FOR THE FIRST 12 HOURS. THE PATIENT THAN FASTED FOR 3 DAYS OF NOT EATING MEAT OR DAIRY PRODUCTS AND RETURNED TO A DIET OF GREENS (KALE, TURNIP, MUSTARDS WITH GARLIC/VINEGAR AND INTAKE OF HERBAL TEA/WATER)
Symptoms started about 2pm. Abdominal pain, nausea, diarrhea, headache, fatigue, muscle soreness, injection site discomfort/pain. Breakthrough bleeding
Information has been received from a medical assistant, for the Pregnancy Registry for GARDASIL concerning an 18 year old female who on 25-MAR-2009 was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL, on 20-MAY-2009 with the second dose of GARDASIL and on 21-SEP-2009 with the third dose of GARDASIL.  There was no concomitant medication.  The medical assistant reported that the patient was pregnant (estimated due date: 05-JUN-2010, estimated last menstrual period: 05-SEP-2009).  No adverse effects were reported.  There was an initial obstetrician visit with unspecified laboratories and a normal ultrasound.  Follow up information has been received from a nurse and a health professional indicating that the patient ended up delivery "very" preterm on 30-MAR-2010.  The nurse stated that the patient was transferred to another hospital because she went into preterm labor and could not be cared for in their community hospital.  It was additionally reported that the patient delivered a baby at 30 week gestation and was transferred to neonatal intensive care unit (NICU).  The baby's experience has been captured in WAES# 0912USA00624B1.  Additional information has been requested.
Extreme swelling, redness below shot from injection point to elbow. General malaise, headache, fever, pain in arm. Allergic reaction - tetanus shot - 4 days duration, aspirin taken to relieve pain.
This spontaneous report was received from a nurse refers to an unspecified patients of unspecified demographics. There was no information about the patients' medical history, concomitant therapies and concurrent conditions. On unknown multiple dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 lot # M000592, expiration date 08-OCT-2017; lot # M000592, expiration date 12-OCT-2017 (strength, dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of -2.37 degree Celsius till an unknown duration. Data logger was involved. No product quality complaint was reported. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
This case was reported by a physician via sales rep and described the occurrence of fever in a 59-year-old male patient who received Shingrix for prophylaxis. On 25th May 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 26th May 2018, 1 days after receiving Shingrix, the patient experienced fever, dizziness, disorientation, lethargy and foggy feeling in head. On an unknown date, the patient experienced driving ability disturbed and inability to work. On an unknown date, the outcome of the fever, dizziness, disorientation, lethargy and foggy feeling in head were recovered/resolved and the outcome of the driving ability disturbed and inability to work were unknown. The reporter considered the fever, dizziness, disorientation, lethargy, foggy feeling in head, driving ability disturbed and inability to work to be related to Shingrix. Additional details were provided as follows: The patient received Shingrix on unknown deltoid. On the following day of vaccination, the patient's body temperature was recorded as 100 degrees F. The patient had significant lethargy and a foggy head. The patient was disoriented and dizzy. All of the patient's side effects resolved within one week. In 2018, less than a week after receiving Shingrix, the patient's side effects significantly impacted his ability to drive and work. The patient also reported that he was a healthy male with no health issues. The patient believed that all of his side effects were related to the Shingrix vaccine.
10/5/13 ER with vomiting and grunting, pulling up legs. Abd. films negative - discharged home. 10/7/13 Presented to ER with vomiting and bloody stool. 10/7/13 - Dx: ileocolic intussusception. Tx: air enema.
Pt vaccinated with DTP developed fever 105 on evening of vaccine administration local reaction at site of injection.
Patient reports palpitations, sore back and neck on left side. Cold symptoms with headache and arm soreness. She was okay at the clinic. She didn't start feeling symptoms until that night  (April 4th 2022).
After I got home the injection site began to get numb. Within that hour my entire left arm down to the fingers my shoulders, chest, upper back, face, lips tongue, throat went numb. I called the pharmacy they told me to take Benadryl and call back in 30 min. I took two Benadryl's, it did not help. I called back and  they said to call my primary care doctor . My Primary care doctor said I was having a stroke, go to the ER. The numbness was not getting better nor worse. They decided to admit me to do further tests. This was around 9pm. I saw a neurologist. He had them do an MRI of my head. I also saw an ENT to make sure there was no blockage with swallowing. By the second day the numbness in my face mouth tongue and throat were getting better but my arm chest and shoulder was not. They discharged me and said follow up w primary care. I met with her on the following Monday 4/12. At that point everything was still numb. She sent in a referral for a neurologist to do more tests. She also ordered a carotid ultrasound. I met with the neurologist on 4/29. I had XRAY and ULTEASOUND 5/10. Neurologist wanted MRI but insurance denied it. I am still numb in my arm, About 3 weeks after injection I started getting lump on my arm about 3 inches from injection. Lump is still there. Pain at the injection site has gotten worse despite them saying it would resolve. If I put pressure on the arm it will wake me up at night. If a blood pressure cuff was put on the arm the numbness worsens. The injection site is still red as well. I have another follow up appt on 6/15 with my primary care. I won't see the neurologist until after the MRI which depends on the insurance.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 09-JAN-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # N020016 and expiry date 17-JUL-2019) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found  This is one of the several reports received from the same reporter.
This spontaneous report as received from a physician via a company representative refers to a 16 year old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 10-FEB-2017, the patient received the third dose of GARDASIL 9, intramuscularly (dose, anatomical location, lot number and expiration date were not reported) for prophylaxis. On the same day (after receiving the dose), the patient experienced extreme swelling and blistering around the injection site. The patient sought medical attention by contacting the physician. It was unknown if the patient received any treatment for this event. The outcome of the event was unknown. The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. In August 2016, reported as dates starting on or after 04-AUG-2016, the patients were vaccinated with improperly stored doses of VAQTA lot # M021124, expiry date 02-FEB-2018 (strength, dose, route and site of administration were not reported). No adverse effect was reported. Administered doses of vaccines experienced the temperature excursion of 35 degrees Fahrenheit for 6 hours and 25 minutes and 47 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous temperature excursions reported. This is one of several cases received from the same reporter. Additional information has been requested.
pt recvd flu vax & devel erythema @ site of inject which persisted for 24 to 48 hrs;
Sharp calf pain. Ultrasound of leg to check for blood clots. No blood clots. Ibuprofen and heat for a few days and it stopped hurting.
About 2 days after vaccination, patient developed a red spot at the injection site. Over the last several days the redness and swelling has expanded to about an inch from the crease of the elbow, and is warm to the touch.  Redness and swelling appears to be spreading at this time, 6 days after vaccination.
Initial unsolicited report received from a consumer on 20-NOV-2017. This case involves a 09-year-old female patient who was vaccinated with a single dose of FLUZONE QUADRIVALENT (batch number was unknown, expiry date, dose, dose in series and site of administration was not reported) via intramuscularly on 17-NOV-2017 at 03:30 PM. Patient's medical history and concomitant medications were not reported. No other vaccines received at that time of vaccination. No illness at the time of vaccination. On 17-NOV-2017 at evening, few hours post vaccination, patient began complaining of pain to the area and then she developed a 7cm in diameter area that had erythema and induration and was warm to the touch. Lab tests were not reported. As corrective treatment, physician when contacted told to treat with Motrin, Tylenol, Benadryl and ice as needed. It was reported that area remains at this time (not recovered), but induration and pain is improving (recovering). List of documents held by sender: none.
N17.9 - AKI (acute kidney injury) (CMS/HCC)
Dizziness,Vomiting, diarrhea, Headache, fatigue, nauseous, Weak
Dizziness and feeling of difficulty swallowing .  Pt symptoms resolve and vitals sign were stable upon evaluation by EMS.  PT refused Treatment or transport
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 02-MAY-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) (strength and route were unknown) (lot#  N020620 and expiration date 22-JAN-2019) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
This spontaneous case reported by a consumer, describes the occurrence of pyrexia (fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 039821A) for COVID-19 immunization. The patient's past medical history included COVID-19 in April 2020. On Apr 28, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 28, 2021, patient experienced pyrexia (fever). The patient treated with ibuprofen, at an unspecified dose and frequency. At the time of the report, pyrexia (fever) outcome: unknown. mRNA-1273 (Moderna COVID-19 vaccine) dosing remained unchanged. Concomitant product use not provided. Patient took second dose May 26, 2021. This case linked to MOD-2021-187084 (patient link).
Breakthrough case admission after 3 vaccines Moderna 2/12/21 lot# 029L20A;  Moderna 3/12/21 lot# 2044A21A;  Moderna 9/2/21 lot# 053E21A
The patient was vaccinated on 6/22/22.  On the afternoon of Friday, June  24th, expired Moderna Covid-19 Vaccine was discovered in the refrigerator.  Lot 54A22A was placed into the refrigerator on 5/19/22 and expired 30 days after on 6/18/22.  The expired vaccine was immediately removed from inventory.  A clinic pharmacist then called the manufacturer, Moderna, to report the incident and inquire about the stability of the expired product.  The pharmacist from Moderna submitted a ?lot analysis? request to evaluate the effectiveness of the affected lot against Covid-19 past the 30 day expiration date.  On Tuesday, June 28th, Moderna responded and stated that: ?The vaccine administered on June 22 and June 23, 2022 from lot number 054A22A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.?  No patient harm resulted.
pt recv vax 20APR96;1wk later devel stiffness in legs, intermittent numbness of hands, transient dizziness, pain @ inj site, & extrapyramidal sx in the legs, arms, & face;MRI of brain lead to dx encephalomyelitis;
The patient tested positive for covid-19 at home on 2/2/22, and originally was stable at home. He had progressive encephalopathy, as well as hypoxia at home and his parents brought him to the emergency room on 2/8/22; admitted for treatment of acute covid pneumonia, with associated hypoxemic respiratory failure.  initiated on IV dexamethasone, as well as remdesivir, on admission CRP was 14.53, Ferritin 194, and D-dimer 0.87; The patient was originally on 2L NC, with brief increase to 6L NC on 2/11. The patient's chest xray was noted to have worsening bilateral infiltrates on 2/11, and he was then treated with one dose of Actemra in addition to other treatments.
Headache, nausea, light sensitivity, muscle aches. Next day, similar symptoms plus diarrhea, fever, no appetite. Day 3, Similar symptoms plus manifestation of "Shingles" (Herpes Zoster" on left side of body. Day 4, same, Day 5, same, Day 6 same. Day 7 began recovery, taking approximately 3 weeks total to do so. Patient reaction greatly affected ability to function, care for family, study for LSAT, prepare for holidays (EX.: no family Thanksgiving). Was prescribed and completed full cycle of Acyclovir and Capsaisin by Dr. on return visit following adverse reaction, on 11/30/2009. Dr. strongly advised patient to secure "ZOSTAVAX" vaccine after full recovery. Vaccine IS covered by patient's insurance, at cost to medical provider of between $175 and $275 dollars per injection.
The patient received the injection on 10/13/08 in the morning.  That evening the patient said he began experiencing symptoms of depression.  The following day, the patient said he said he was still experiencing the depressive symptoms, but lacked suicidal thoughts.  Four days after receiving the injection, the patient said the symptoms were improving, but were still present.  One week from the date of receiving the injection, the patient said the symptoms were gone.  The patient had no history of depression or any reasons for the new onset of depresssion.
pt recv vax 19MAR97 & 23MAR97 devel arthralgia in knees, elbows, & finger joints;pt was treated w/steroid therapy;
Tired; Fever of 102.1; headache; Aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102.1), HEADACHE (headache), PAIN (Aches) and FATIGUE (Tired) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A02A and 002A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), ANASTROZOLE, VITAMIN D [VITAMIN D NOS] and MULTIVITAMIN [ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CYANOCOBALAMIN;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced PYREXIA (Fever of 102.1), HEADACHE (headache) and PAIN (Aches). On an unknown date, the patient experienced FATIGUE (Tired). The patient was treated with MELOXICAM for Fever, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 31-Mar-2021, HEADACHE (headache) and PAIN (Aches) outcome was unknown. At the time of the report, PYREXIA (Fever of 102.1) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.9 (High) low fever and 102.1 (High) fever.         Treatment information included tylenol and meloxicam.
Approximately 6 hours after the injection I developed the sensation of warm water running down my left leg. It came in pulses/surges, maybe every 30 seconds to a minute, and lasted at least 60 hours. It was worse when standing but also occurred when sitting. The sensation traveled from behind my knee, down my calf, and along the left side of my foot. An hour or two after this experience began, I also developed tailbone pain. The tailbone pain lasted approximately 48 hours. As the other side effects of the vaccine subsided (i.e., fever, joint aches, headache, etc.), the "warm water" sensation dissipated.
22SEP93 during the morning pt became very lethargic; no fever spitting up saliva but more than usual; wouldn't take a bottle pt was taken to MD;
Patient had ongoing symptom described as 'bubbling' or 'fizzing' in back of head or as 'bubbles flowing up a corridor in the back of the head' for ~1 year prior to 1st vaccine dose . Symptom would only occur once every few days/weeks and would occur momentarily or for a few minutes of the day then dissipate.  After receiving 1st vaccine dose, patient noticed symptom as they proceeded to waiting area but then it had gone away. About an hour later the symptom returned and persisted almost non stop. Symptom has since persisting and occurring daily but has changed and feels more like "electricity" or  smaller bubbled/fluid/fizzing being forced or moved around in back of head and neck. It seems to occur more frequently simultaneously with stomach symptoms like stomach growling. Also causes 'impending doom' feeling.   MRI and MRA of the head and neck were performed and were unremarkable. Patient was treated with Topamax for nerve pain and it did seem to help subdue symptom but did not resolve. Topamax was d/c because of itchiness of the skin and dermatographism. 5 weeks post after d/c of Topamax,  itchiness/dermatographism are persisting.
Dizzy, diaphoretic, weak, nausea, felt above symptoms immediately on a lifted head off pillow in AM to get out of bed, felt fine if laid perfectly still. Symptoms started to subside in early afternoon. Felt fine about 4:30PM
Exacerbation of chronic headache. Post-injection, headache became intractable and more severe in nature. We are working with pain medications as well as modulating the immune/inflammatory response to control pain. Outcome unknown at this time because we just initiated treatment.