chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bullous impetigo; blistering around the injection site; bruising around the injection site; This case was reported by a physician via sales rep and described the occurrence of bullous impetigo in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On 14th August 2019 11:30, the patient received the 2nd dose of Bexsero (intramuscular). In August 2019, 12 hrs 30 min after receiving Bexsero, the patient experienced bullous impetigo, injection site blisters and injection site bruising. The patient was treated with antibiotics nos. On an unknown date, the outcome of the bullous impetigo, injection site blisters and injection site bruising were unknown.   It was unknown if the reporter considered the bullous impetigo, injection site blisters and injection site bruising to be related to Bexsero.  Additional details were provided as follows: The patient received Bexsero around 11:30 AM and around midnight, she reported developing blisters. The patient had blistering around the injection site, one very large and other small ones. On 15th August 2019, the patient was seen by the health care professional. The physician stated, she had never seen this before and this looked like bullous impetigo but she was not sure so covered her bases with antibiotics.
It was reported that a patient  (2 of 6) received a Fluzone SV '01-'02 vaccination, Lot number UO590AA administrated IM on 09/26/01. Reportedly, the patient developed a local reaction  consisting of pain, redness and warmth at the injection site. Patient was treated symptomatically and the symptoms resolved. Linked cases U2001-01025, U2001-01196, U2001-01197, U200101198 & U2001-01199.
throat numbness, no throat swelling about 3mm p/receiving the inj;felt as though hands became more edematous however is able to remove rings w/o any diff
No additional adverse effects; the patient was administered the first dose on or around 12/24/19 (Patient age: 35 years old); This spontaneous report was received from a pharmacist referring to a 35-year-old male patient. The patient's concurrent condition, medical history and concomitant therapy details were not reported.  On an unknown date in approximately December 2019 (also reported "on or around 24-DEC-2019"), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, lot# and expiry date not reported) via unknown route as prophylaxis (product administered to patient of inappropriate age). On 16-MAR-2020, the patient was vaccinated with second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # R025725, expiry date 25-MAY-2021 (strength and dose were not reported). No additional adverse effects reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; manufactureraddress: ; manufacturercity:; manufacturerstate: ; manufacturercountry: ; devicelotnumber: R025725; expirationdate: 25-MAY-2021; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Dizziness immediately after injection, anxiety, questionable tongue thickening.  Then canker sores on tongue, lips swollen later in day and next day.  No breathing issues.
3hr p/vax pt noticed progressive redness, tenderness, swelling & hot to the touch area on rt upper anterior arm;to MD on 18APR97 w/arm measuring 22cm x 22cm;red, tender, hot to touch & swollen 2cm in depth;t101.5, BP 170/102;P96;R20;to ER
fever, chills, myalgias, SOB, increase in baseline cough. Some symptoms improving after 24 hours of onset but SOB and increase in cough still present at 72 hours post-vaccination.
Very painful, red, got to touch, raised, measure about a quarter in diameter, very itchy on 6/7/2017 most of the day. Applied ice 20 minutes on and off throughout the day to try and decrease swelling and soothe the itching. Never scratched it, by night about the size of a golf ball. By morning, measured 2.8 inches. Notified pharmacy and they communicated with their clinical manager. Went to my primary care doctor and was prescribed Bactria 800 mg BID for 7 days.
A vaccine that was drawn up into a syringe on 7/7/21 and placed into a refrigerator was accidentally used on 7/14/21. It should have been discarded on 7/7/21, after a no show appointment.  It was placed into the refrigerator and then accidentally used on 7/14/21. The nurse thought it was a fresh syringe from 7/14/21.
patient had a flareup of her fibromyalgia and this event occurred about 3 days after injection
swollen arm; warm to touch at the injection site; hardness at the injection site; redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), VACCINATION SITE WARMTH (warm to touch at the injection site), VACCINATION SITE INDURATION (hardness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included PARACETAMOL (TYLENOL) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 02-Mar-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 PERIPHERAL SWELLING (swollen arm), VACCINATION SITE WARMTH (warm to touch at the injection site), VACCINATION SITE INDURATION (hardness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). At the time of the report, PERIPHERAL SWELLING (swollen arm), VACCINATION SITE WARMTH (warm to touch at the injection site), VACCINATION SITE INDURATION (hardness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
COVID-19; FEVER; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and PYREXIA (FEVER) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Psoriasis.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19) and PYREXIA (FEVER). At the time of the report, COVID-19 (COVID-19) had resolved and PYREXIA (FEVER) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment medications were reported.  Company Comment: This spontaneous case concerns a male patient of unknown age who received the non-company product, co-suspect drug Adalimumab for Psoriasis and experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred on unknown interval after receiving the first dose of mRNA-1273 vaccine. The clinical presentation, diagnostic evaluation and treatment information were not provided in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age who received the non-company product, co-suspect drug Adalimumab for Psoriasis and experienced the unexpected, non-serious adverse event of special interest of COVID-19 which occurred on unknown interval after receiving the first dose of mRNA-1273 vaccine. The clinical presentation, diagnostic evaluation and treatment information were not provided in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Knot on right upper arm; extreme pain and soreness. Injection given 4/28/03; states was seen in ER 2 times; was seen in FPC 5/8/03. Knot approximately size of half dollar, palpable and very tender. MRI right arm ordered.
This spontaneous report was received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date from 02-APR-2018 to 15-MAY-2018, the patient was vaccinated with an improperly stored dose of VARIVAX (Lot #: N021315, Exp Date: 07-AUG-2019) (Lot#: N029632, Exp Date: 23-OCT-2019) or (Lot#: N030571, Exp Date: 31-OCT-2019) for prophylaxis, which had a temperature excursion of 6.1F for 5 minutes. Previous temperature excursion was 5.9 F for 45 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK) (no more information was provided). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1805USA009899:Original Case : 1805USA006787; US-009507513-1805USA009900:Original Case : 1805USA006787; US-009507513-1805USA009901:Original Case : 1805USA006787; US-009507513-1805USA009902:Original Case : 1805USA006787; US-009507513-1805USA009903:Original Case : 1805USA006787; US-009507513-1805USA009904:Original Case : 1805USA006787; US-009507513-1805USA009905:Original Case : 1805USA006787; US-009507513-1805USA009906:Original Case : 1805USA006787; US-009507513-1805USA009907:Original Case : 1805USA006787; US-009507513-1805USA009908:Original Case : 1805USA006787; US-009507513-1805USA009909:Original Case : 1805USA006787; US-009507513-1805USA009910:Original Case : 1805USA006787; US-009507513-1805USA009911:Original Case : 1805USA006787; US-009507513-1805USA009912:Original Case : 1805USA006787; US-009507513-1805USA009913:Original Case : 1805USA006787; US-009507513-1805USA009914:Original Case : 1805USA006787; US-009507513-1805USA009915:Original Case : 1805USA006787; US-009507513-1805USA009916:Original Case : 1805USA006787; US-009507513-1805USA009917:Original Case : 1805USA006787; US-009507513-1805USA006787:Original Case : 1805USA006787; US-009507513-1805USA009919:Original Case : 1805USA006787; US-009507513-1805USA009920:Original Case : 1805USA006787; US-009507513-1805USA009921:Original Case : 1805USA006787; US-009507513-1805USA009922:Original Case : 1805USA006787; US-009507513-1805USA009923:Original Case : 1805USA006787; US-009507513-1805USA009924:Original Case : 1805USA006787; US-009507513-1805USA009925:Original Case : 1805USA006787; US-009507513-1805USA009926:Original Case : 1805USA006787; US-009507513-1805USA009927:Original Case : 1805USA006787; US-009507513-1805USA009928:Original Case : 1805USA006787; US-009507513-1805USA009929:Original Case : 1805USA006787; US-009507513-1805USA009930:Original Case : 1805USA006787; US-009507513-1805USA009931:Original Case : 1805USA006787; US-009507513-1805USA009932:Original Case : 1805USA006787; US-009507513-1805USA009933.
pt recv vax & devel myalgia & arthralgia, abd pain followed by change of mental status;
an approximately 4 inch diameter reddened, warm-to-the-touch area of skin directly under the injection site developed approximately 1 week following the injection.
My eyes hurt and subsequently had discharge associated with the pain.  Lasted several days.  Pain subsided however discharge remained though decreased.  Upon receiving the booster on November 2, 2021, eye pain resumed and discharge has increased.  Eye discharge is thicker than tears and will sometimes awake with crust having formed on lashes.  Now at one month since booster, discharge is not constant but present and eyes feel tired and strained.  Doesn't impact daily living or vision.
Dizziness, light headedness, jitters, tachycardia, high blood pressure; onset from right after injection; lasted 2 hours.
Initial health care professional report received on 29 Oct 2010: This patient was vaccinated with MENVEO (batch 090601A), at an unknown dose intramuscularly on 21 Oct 2010. Patient was administered only the MenCYW -135 liquid component, no adverse reaction was reported. The treating physician details were not reported. Causality assessment was not reported.
This case was reported by a physician via a sales representative and described the occurrence of possible sepsis in a 14-month-old female subject who was vaccinated with Pediarix, MMR and Varicella for prophylaxis.  In January 2008 the subject received unspecified dose of Pediarix (.5 ml, unknown), unspecified dose of MMR vaccine (unknown) and unspecified dose of Varicella vaccine (unknown).  In January 2008, 1 day after vaccination with Pediarix, MMR vaccine and Varicella vaccine, the subject experienced fever of 104 degrees Fahrenheit and inconsolable crying.  The subject was taken to the emergency room where she received a full septic work up and a CAT scan.  No results were provided.  Five days following vaccinations, the fever and inconsolably crying persisted and the subject was taken to an urgent care facility.  This case was assessed as medically serious.  At the time of reporting the outcome of the events were unspecified.
The patient had a seizure about an hour after getting the immunization.  He continued to have mild Seizures for 1-2 hours before returning to normal.
Information has been received from a health professional concerning a patient who was vaccinated with a dose of Zostavax. Subsequently the patient experienced redness at the injection site and soreness at the injection site. The patient recovered the next day. No further information was provided. Additional information has been requested.
Right cervical lymphadonopathy about 2-3 weeks after 2nd dose of Pfizer.
Patient was given an expired vaccine, vaccine expired at 1230pm, and was given at 132pm, patient was contacted and came in 3/5/21 to be revaccinated.
5-4-12 Mother report 5 mo. old with red dots to scalp & neck. Slight fever 5-3-12, infant alert, oriented report no distress. Advised PCP visit to evaluate rash. ER Dr at hospital advised was "a measle like rash due to live vaccine - ROTATEQ. Mother reports a few more spots on legs & arms. 5-8-12 Check on infant-mother reports infant fine & rash fading.
This was a vaccine administration error. Patient received first Fluzone injection on 9/26/23 and parents brought patient into a Flu Clinic on 10/7/23 where he received dose #2 too early. Received 11 days apart instead of 28 days. No adverse side effects occurred.
Patient was given the COVID 19 Bivalent Booster past the Beyond Use Date. The BUD date was 01/13/2023.  The patient received the vaccine on 01/16/2023.
Symptoms noticed upon waking.  Urticaria involving face (left side mainly), right AC fossa, glans penis.  Mild left upper eyelid edema.  Treated with Xyzal 5mg daily.
Arm has a red mark; Arm has like a rash, about 3x2 inches in size, spreading, turning further to the left; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Arm has a red mark) and VACCINATION SITE RASH (Arm has like a rash, about 3x2 inches in size, spreading, turning further to the left) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 032NM20A) for COVID-19 vaccination.     The patient's past medical history included Fungal infection (Medical history reported as fungal infection.). Concurrent medical conditions included Thyroid activity decreased (Thyroid over 25 year), Milk allergy, Acid reflux (oesophageal) and Fungal infection (on toe). Concomitant products included LEVOTHYROXINE for Thyroid activity decreased.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm has a red mark). 18-Feb-2021, the patient experienced VACCINATION SITE RASH (Arm has like a rash, about 3x2 inches in size, spreading, turning further to the left). On 20-Feb-2021, VACCINATION SITE ERYTHEMA (Arm has a red mark) and VACCINATION SITE RASH (Arm has like a rash, about 3x2 inches in size, spreading, turning further to the left) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VACCINATION SITE RASH (Arm has like a rash, about 3x2 inches in size, spreading, turning further to the left) to be not related. No further causality assessment was provided for VACCINATION SITE ERYTHEMA (Arm has a red mark).    Patient reported that some rubbing alcohol may have come into contact with the rash, while attending to an insect bite above it.  Concomitant drugs included acid reflux medication and topical medication for a fungi infection on their toe.  Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up was received on 28-APR-2021 in which, past medical history of patient ,concomitant medication, Second dose details of vaccine, causality of Vaccination site rash  were updated .
Swollen eyes; Face bright red; Face burning; Face and neck started to itch; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 05Apr2021 at 13:30 (at the age of 38-years-old), as a single dose for COVID-19 immunisation. Medical history included breast cancer, hypothyroidism and bipolar 2. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), lamotrigine (LAMICTAL) and clonazepam (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 14:30, 48 hours after the vaccination, the patient experienced face and neck started to itch. On 08Apr2021, following morning, patient woke up with swollen eyes, face bright red, itching, and burning. Therapeutic measures were taken as a result of adverse events and included treatment with benadryl and steroids. The clinical outcome of the event face and neck started to itch, swollen eyes, face bright red, face burning was recovering at the time of the report.   No follow-up attempts are possible. No further information is expected.
Angina happened in jaw and chest; A spontaneous was received from a consumer, concerning herself, a 75 years old female patient who received Moderna's COVID-19 vaccine and experienced angina/angina pectoris.   The patient's medical history included open heart surgery for cardiovascular problems. Concomitant medications prn nitro sublingual.     On 25 Feb 2021, the patient received their first of two planned doses of mRNA-1273. On 25-MAR-2021, the patient received their second of two planned doses of mRNA-1273 (Batch no: 006B21A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 25 Mar 2021, 20 minutes after the second dose of vaccine, while driving patient experienced chest and jaw pain, self treated with nitro under the tongue and it went away after 15 min and was able to continue driving. The angina made her tired, restless and was afraid that she might have another one.  Action taken with mRNA-1273 in response to event was not applicable.  The outcome of the event angina was considered resolved.; Reporter's Comments: Based on reporter's complaints and history of heart surgery with recurrent angina the event is assessed as unlikely related to mRNA-1273. Further information has been requested.; Sender's Comments:  MOD-2021-057914:Case for first dose
pt recv vax & exp chills, fever 102.9, h/a, nausea & mom gave APAP & bedrest & contacted MD 5/11/99;
My symptoms began as a sore throat and mild sniffles. I tested positive for COVID-19 on February 24, 2023 and began taking PAXLOVID on the 25th. Within 2 days I was testing negative but wasn't feeling better, but not worse. As of today I have no lingering symptoms.
Painful swelling of the entire left leg and foot.  MD  ordered x-rays, ultrasound and MRI to rule out blood clot, cysts or tears.  MRI did show two meniscus tears, however they were not new and had not been bothersome prior to the swelling.  Referred to an orthopedic knee doctor who injected Cortisone into my left knee to reduce the inflammation.  Which it did.  The leg continues to have intermittent pain but the swelling is gone.  The swelling lasted four(4) weeks.
16 yo M w/ no known chronic medical conditions (but s/p ASD and mitral valve repair in 2015), presents w/ constant R-sided CP since yesterday; woke up w/ R shoulder pain that radiates to his R pinkie. The CP is worse w/ movement of the torso, specifically while bending forward. No shortness of breath, DOE, leg swelling, LH, diaphoresis, n/v/d, abd pain. No recent illnesses, fevers/chills, cough, nasal congestion. No h/o similar sx. No family h/o cardiac disease. He had congenital mitral prolapse and ASD that were repaired in 2015; he was told by his interventional cardiologist that the repairs were successful and that he does not need regular follow-up.  Worked out heavily 2 days ago (mostly chest/arms weightlifting
Large red welt with redness noted on entire deltoid region of arm x 5 days on 9/4 symptoms of shingles started. Shingles persisted x 2 wks. (? coincidence).
Felt faint/sweaty 15 minutes after the vaccine was given. Pale and moist appearing. BP 80/40 (pulse 66), O2 sat 99%. Given water and felt better after rest. BP 132/76 (pulse 74).
Started running fever few hrs p/inject & by MN had fever of 104.8 called who ordered advil; fever down to 101-102 this morning; rt leg has knot w/redness & hot to touch; won't put any weight on rt leg;