chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a female patient who was vaccinated with a dose of Pneumovax 23 (lot # 654593/0358F). Subsequently, the patient developed redness and swelling at the injection site. Medical attention was sought. The patient's outcome was unknown. A review of the Laboratory Information Management System data revealed that the lot conformed to all required testing at the time of product release. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Follow up information has been received from a physician concerning the 54 year old white female teacher with allergies to sulfa and SUPRAX who on 05-SEP-2006 received a dose of Pneumovax 23 (lot # 654593/0358F) in the left arm. The patient presented 2 days later with increased redness, swelling and warmth in the left upper extremity. She was treated with AUGMENTIN 875 mg BID. On 08-SEP-2006 she developed fever and continued with present course of antibiotics. On 12-SEP-2006 her cellulitis was much improved. She continued with 10 days of antibiotics but was reported to be recovered on 12-SEP-2006. Additional information is not expected.
headache; high inflammation maker; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (headache) and C-REACTIVE PROTEIN INCREASED (high inflammation maker) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache) and C-REACTIVE PROTEIN INCREASED (high inflammation maker). At the time of the report, HEADACHE (headache) had resolved and C-REACTIVE PROTEIN INCREASED (high inflammation maker) had not resolved. Not Provided          No Concomitant medications were reported.  Treatment medications taken were steroids.  Patient had appointment with a rheumatologist.    Action taken with mRNA-1273 in response to the events were Not Applicable.
This spontaneous report as received from nurse practitioner refers to a patient of unknown age and gender. No medical history and concurrent conditions reported. On 22-JUN-2015, the patient was inadvertently administered with improperly stored MMR II vaccine, rHA type, lot # K002816, expire date: 25-FEB-2016 (dose, route, therapy type not reported). No adverse effects reported. No product quality complaint reported. This is one of several reports received from the same source. Additional information has been requested.
Swelling of face, pounding headache, chills, muscle weakness and soreness, burning sensation in throat, itchy
Doctor advised that these reactions were because dose was given to her improperly; Rash at injection site; Pain at injection site; Oval outline (COVID arm) at injections; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Doctor advised that these reactions were because dose was given to her improperly), VACCINATION SITE RASH (Rash at injection site), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Oval outline (COVID arm) at injections) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE RASH (Rash at injection site), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Oval outline (COVID arm) at injections). On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Doctor advised that these reactions were because dose was given to her improperly). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, INCORRECT DOSE ADMINISTERED (Doctor advised that these reactions were because dose was given to her improperly), VACCINATION SITE RASH (Rash at injection site), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE SWELLING (Oval outline (COVID arm) at injections) had resolved.            Concomitant product use was not provided by the reporter.  Additional treatment medication was antibiotics.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Added dose 2. Added event (incorrect dose administered) and added event outcome was recovered.
Arthritis; Site of vaccination painful; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis) and VACCINATION SITE PAIN (Site of vaccination painful) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (moderate to severe rheumatoid arthritis).   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (Site of vaccination painful). On an unknown date, the patient experienced ARTHRITIS (Arthritis). At the time of the report, ARTHRITIS (Arthritis) had not resolved and VACCINATION SITE PAIN (Site of vaccination painful) had resolved.            There was no reported medical history.  Concomitant medications details were not reported.  On an unknown date, the patient had arthritis which was bad in knees. In 2021,the patient had sore arm.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The reporter's causality for the events of Arthritis and Site of vaccination painful was not provided for Rinvoq.  No treatment information was reported.  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.
Patient was seen at the hospital and they saw rash and reported to health department. Child was not seen at Dr office.
red dots on arm, welt like; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (red dots on arm, welt like) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (red dots on arm, welt like). At the time of the report, URTICARIA (red dots on arm, welt like) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Information has been received from a nurse practitioner referring to 1 year old male patient with no known drug allergy. The patient had no illness at time of vaccination. The patient's birth weight was 9lb 1oz. Concomitant therapies included VARIVAX and hepatitis a virus vaccine (unspecified). On 03-MAY-2016 at 10:35, the patient was vaccinated with M-M-R II lot # L026553 dose 1, subcutaneously in the right thigh. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Worked until 5:30 PM as Infant/Toddler Childcare staff. 5:45 PM attended exercise class, began stretching because back "felt stiff", sudden onset of sharp pains in upper back under scapula. Difficulty sleeping that night, treated with ibuprofen and heat with some relief. Called to report pain, advised to call Public Health. No other symptoms such as wetness, rash, vomiting.
Started w blurry vision, eye pain w extreme light sensitivity, sharp headache on left side top of head, nausea. The pain was excruciating, never had a headache that felt so bad. Lasted 36 hrs. Next day felt dizzy, headache, pain increased when bending or stretching. Slight pain 72 hrs later when sneezing and feeling of chest pain. Light sensitivity continues.
Patient reported yellow, matted eyes, bronchitis, constant cough a few days after receiving FLUZONE HD. Pt was prescribed CIPRO & prednisone by her physician. Also fever & in bed approximately 9 days.
Chest pain; I have the AstraZeneca on July 24 the 1st shot and then I had Pfizer 2nd one; This is a spontaneous report from a contactable consumer (patient, self-reported). A 59-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0179 and expiry date was not reported), via an unspecified route of administration, on 31Jul2021 (age at vaccination: 59 years), as a single dose for COVID-19 immunization and first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19, lot number and expiry date were not reported), via an unspecified route of administration, on 24Jul2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that on 01Aug2021, the patient experienced Chest pain and I have the AstraZeneca on 24lthe 1st shot and then I had Pfizer 2nd one on an unspecified date in 2021. The patient stated, "Well little bit concerned, I have the AstraZeneca (Further not clarified hence captured as Unspecified vaccine) on July 24 the 1st shot and then I had Pfizer 2nd one the Pfizer (Confirmed as Covid 19 vaccine) Yes, the Pfizer would be second one the 1st one is 24Jul AtraZeneca the second one was Pfizer I took it on July 31st on the Aug 1st, I had chest pain and I didn't go and see doctor today." The patient stated, "the reason I called is just wanna ask how bad would this chest pain going to be and how long would it it last normally the CDC has indicated it last may be 14 days." Further probing could not be done as the consumer was not willing to provide further information. Outcome of the events was unknown.
Muscle aches, 101.6  fever, headache, weakness, lethergy, can?t touch the injection site, slight dizziness, nausea
She broke out in hives on June 4, they haven't cleared up yet.  She was experiencing intense joint pain this morning (June 9) and we had to take her to the ER.  They did blood tests, stated that her blood test for inflamation was mildly high.
Initial misuse report received from a healthcare professional (nurse) on 16 September 2013 and the case was received on 21 March 2014. It was reported that the patient (information regarding the patient was not provided) had received a subcutaneous dose of FLUZONE HD (batch number, dose in series and site of administration was not reported) on an unspecified date. The patient received FLUZONE vaccine subcutaneously instead of intramuscular. No adverse event was reported. List of documents held by sender: none.
Developed tinnitus in right ear (same side as injection) within days of 2nd dose that is still ongoing 8+ weeks later.  Never had it before shot.; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on 13Feb2021 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included allergic to sulfa drugs and shrimp. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982) via an unspecified route of administration in the left arm on 23Jan2021 as a single dose for COVID-19 immunisation. On 15Feb2021, the patient developed tinnitus in right ear (same side as injection) within days of 2nd dose that was still ongoing 8+ weeks later and never had it before shot. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
biphasic varicella rxn;pt recv vax 3JUL96 16 days later 10 varicella-like lesions faded w/in 2 days;mood & activity chang-quietness, fussier, wants to be held a lot x 2 wk;23JUL-27JUL t102-103;5AUG-7AUG productive cough, 3 vesicles lesions;
pt recv vax 2APR97 & 10JUN97 pt exp afebrile clinical mumps & a marked area of rt parotid swelling;lab eval revealed acute mumps antibody of <1:8, %segs of 40 (decreased) & lymph of 52 (elevated);11JUN97 pt recovered;
No additional AE; VARIVAX was inadvertently administered via intramuscular route rather than intended subcutaneous; This spontaneous report has been received from a nurse prescriber concerning male patient of unknown age. His concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 09-FEB-2023, the patient was inadvertently vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml, administered as prophylaxis, lot number W022293 with expiration date 13-JUL-2024. The patient was vaccinated intramuscularly instead of the intended subcutaneous route (Incorrect route of product administration). No additional adverse events were reported (No adverse event).
On the 10th day had a round red rash about 3 1/2? in diameter and a hard lump in middle. It itches alot
Total body hives. Suspected egg allergy. MMR at 11:45 on 10/3/14. Ate eggs at 9AM on 10/4/14. Hives at 12:30pm on 10/4/14.
Swelling and hard lump at injection site. Pt is to be given 1/3 to 1/2 tsp liquid Benadryl q 4=6 hrs prn and to return to clinic if not better in 2 days.
Approximately 2 to 3 weeks after my second Moderna shot, I began experiencing pain radiating from my shoulders to my hands.  Within days after that, I started to feel my entire body becoming inflamed.  I am experiencing excessive inflammation throughout my body.  Lab tests conducted two days ago found my sedimentary rate at thirty-four.  As a result of the inflammation, I have become unable to use my hands to perform menial functions as dressing myself, where my hands are unable to pull socks over my feet.  The inflammation continues today.  The pain level experienced as a result of the increased inflammation as resulted in significant diminished capacity for performing my daily routine.
RED AREA TO LEFT DELTOID WITH WELPS AND WARM TO TOUCH. ADVISED BY PROVIDER TO TAKE TYLENOL AND USE COLD PACKS FOR PAIN. GHOSH WANTS TO ALSO NOTE HERE, ALTHOUGH IT'S NOTED IN #17 THAT THE KINRIX (DTaP + IPV) WAS GIVEN IN LEFT ARM, INTRAMUSCULARLY.
Ability to walk limited; Cant sleep; Night sweat; Right knee swelled\right knee swelled to the size of a melon; Pain high; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Right knee swelled\right knee swelled to the size of a melon), PAIN (Pain high), GAIT DISTURBANCE (Ability to walk limited), INSOMNIA (Cant sleep) and NIGHT SWEATS (Night sweat) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included INSULIN GLARGINE (BASAGLAR) from 11-Jan-2018 to an unknown date, METFORMIN from 11-Jan-2018 to an unknown date, LISINOPRIL from 11-Jan-2018 to an unknown date and EMPAGLIFLOZIN (JARDIANCE) from 11-Jan-2018 to an unknown date for an unknown indication.    On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PAIN (Pain high). On 17-May-2021, the patient experienced JOINT SWELLING (Right knee swelled\right knee swelled to the size of a melon). On 18-May-2021, the patient experienced NIGHT SWEATS (Night sweat). On an unknown date, the patient experienced GAIT DISTURBANCE (Ability to walk limited) and INSOMNIA (Cant sleep). The patient was treated with CORTISONE at a dose of 1 dosage form, Right knee; PREDNISONE at a dose of UNK dosage form; METHOTREXATE at a dose of UNK dosage form and Physical therapy for Joint swelling. At the time of the report, JOINT SWELLING (Right knee swelled\right knee swelled to the size of a melon), GAIT DISTURBANCE (Ability to walk limited), INSOMNIA (Cant sleep) and NIGHT SWEATS (Night sweat) outcome was unknown and PAIN (Pain high) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, Aspiration joint: abnormal (Inconclusive) 55 milliliters of fluid was removed from the patients right knee.. On 07-May-2021, Aspiration joint: abnormal (Inconclusive) 35 milliliters were removed from the right knee.. On an unknown date, Blood test: unknown unknown. On an unknown date, Magnetic resonance imaging: unknown (normal) No structural damage.         This case was linked to MOD-2021-229819 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Initial Additional Document received and contains significant information. updated with patient demographic information, concomitant drug information, non serious events and its outcome.
Narrative: COVID fully vaccinated, Admitted for cough & SOB, found to be COVID positive
HIGH FEVER 102.0 THE FOLLOWING DAY AFTER VACCINATION AND REDNESS WITH SWELLING ON RIGHT ARM WHERE VARICELLA WAS ADMINISTERED..
she has a hard time breathing; woke up all wet; has been sick for 4 days; She has a hard time walking because of the hip pain; She also reports muscle pain, aches; She ran a fever; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (she has a hard time breathing), NIGHT SWEATS (woke up all wet), ILLNESS (has been sick for 4 days), ARTHRALGIA (She has a hard time walking because of the hip pain) and MYALGIA (She also reports muscle pain, aches) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes (She has diabetes) and Arthritis (She have bad arthritis from before).    On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced DYSPNOEA (she has a hard time breathing), NIGHT SWEATS (woke up all wet), ILLNESS (has been sick for 4 days), ARTHRALGIA (She has a hard time walking because of the hip pain), MYALGIA (She also reports muscle pain, aches), PYREXIA (She ran a fever) and VOMITING (vomiting). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 3 times a day. In December 2021, ILLNESS (has been sick for 4 days) had resolved. At the time of the report, DYSPNOEA (she has a hard time breathing), NIGHT SWEATS (woke up all wet), ARTHRALGIA (She has a hard time walking because of the hip pain), MYALGIA (She also reports muscle pain, aches), PYREXIA (She ran a fever) and VOMITING (vomiting) had not resolved.            She takes a lot of medications, but did not specify which ones. She received a full dose of the vaccine for her third dose because she has diabetes, and they said she needs a third dose. She got better, then worse.  She is still experiencing symptoms.
Patient walked back to front desk to schedule second dose appointment, at 10:36am told the clerk that he felt dizzy and fell backwards hitting his head on the door frame, nurses arrived at 10:39am patient spontaneously regained consciousnesses, very pale, breathing and able to state his name. Nurses assessed blood pressure, orientation, had patient role to side lying due to potential of vomiting, patient reported feeling nauseated,  blood pressure at 10:42am 80/60, cool, wet paper towels applied to forehead and nape of neck.  Patient pallor improving, 10:47am 108/80, kept patient lying for 2-3 more minutes, patient able to independently sit up and lean against the wall, took some sips of ginger ale and ate 3-4 crackers.  Nurse sat with patient for 10 minutes, patient stated he could stand and wall independently, had patient come into exam room until EMS arrived. 11:01 EMS arrived, patient alert, oriented, sipping ginger ale, reports "head hurts and there is a knot" touching the back right crown of his head. EMS assessed blood pressure 100/60, blood glucose 125 non fasting. Encouraged patient to go to the ER via ambulance or by car, to be seen by physician. Nurse also encouraged follow up in the ER related to head injury.  Patient verbalized understanding and left clinic with EMS to sign waiver to refuse transport to ER.  Called patient at 2:08pm, patient reports "feeling fine", in Dr office waiting to be seen.  Patient will call nurse back to give update after seeing his physician.
Patient complaint of fatigue/(sleepy) and sensitive to light immediately  15 minutes after getting Janssen & Janssen vaccine
On visit to MD office on 09/06/2013, pt reports that she has an area of redness after receiving vaccination on 09/03/2013. Left upper forearm (anterior portion) shows area of erythema with irregular edges - with 20 cm at its greatest length and 14 cm at is greatest width. Area feels warm to touch.  No open areas, exudate noted. Denies itching; states "it hurts a little." Report given to MD. MD reports he will order prednisone for pt to take.
My period shortened in length starting the month after I was vaccinated. Specifically, the luteal phase of my period shortened from 14 days to 9 days and has stayed consistent at 9 days ever since.
First I have swollen lymph nodes under left armpit. And then I started having a bounding pulse on the right side of my neck. And it won?t stop.
Extreme exacerbation of CIDP symptoms.  Weakness and paralysis of extremities, inability to walk, loss of sensation in hands and feet, marked increase in neuropathic pain
I don't know where else to report this, but after my initial shots in March/April 2021, my psoriasis completely went away! It started to come back just before I got my first booster in October 2021, and then cleared up again until late May, 2022.  I just got my second booster in June 2022, so I don't quite know if the psoriasis will go away again, but fingers crossed! This is a wonderful side effect that you all might want to know about!
Within minutes of flu vaccine administered patients face became flushed and swollen - c/o throat fullness and wheezing.