chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red patch on upper arm; itchy patch on upper arm; Raised rash on arms and legs, knees, waist; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (red patch on upper arm), VACCINATION SITE PRURITUS (itchy patch on upper arm) and RASH PAPULAR (Raised rash on arms and legs, knees, waist) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 39K202A and 039k202A) for COVID-19 immunization.     The patient's past medical history included No adverse event (No medical history or conditions.). Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (LO LOESTRIN FE) for Birth control.   On 30-Dec-2020 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2021 at 5:06 PM, the patient experienced VACCINATION SITE ERYTHEMA (red patch on upper arm) and VACCINATION SITE PRURITUS (itchy patch on upper arm). 07-Jan-2021 at 5:06 PM, the patient experienced RASH PAPULAR (Raised rash on arms and legs, knees, waist). On 08-Jan-2021, VACCINATION SITE ERYTHEMA (red patch on upper arm), VACCINATION SITE PRURITUS (itchy patch on upper arm) and RASH PAPULAR (Raised rash on arms and legs, knees, waist) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include Lo Loestrin for birth control.  No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt recvd vax & 3 to 4 hrs following vax pt exp swelling of arm from shoulder to elbow, induration, redness, & warmth @ the inj site, & fever; pt recovered in approx 1 wk;
Swollen gland/lymph node in left armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 16:00 (Lot number: FD7218) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0172, Location of injection: Arm Left), administration date: 04May2021, when the patient was 31 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8729, Location of injection: Arm Left), administration date: 13Apr2021, when the patient was 31 years old, for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 15Dec2021, outcome "recovering", described as "Swollen gland/lymph node in left armpit". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient received no other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination.  Follow-up attempts are completed. No further information is expected.
Swollen hands. Knees and ankles. Stiff joints in hands, knees, ankles, and neck.
Patient required admission for abdominal pain, malaise, jaundice. 12/22/06 SGOT 285, SGPT 966, Total Bilirubin 0.9. 12/12/06 HCV PCR (+) but 655 then 10, Hep Bsag (+), HCV ab (+), HIV (-), Hep Delta (-), Hep Bsab (-), Hep Bc IgM (+).  1/26/07 Received medical records from hospital which reveal patient experienced jaundice, tender hepatomegaly, malaise, nausea, headaches & cough. Thought to have hep b reactivation, probable drug induced hepatitis & probable ETOH hepatitis as well.  Tx w/steroids & thiamine & responded very well.  D/C to home on tapering steroids & thiamine; all other meds d/c; to be followed by GI & ID as outpatient. FINAL DX: subacute hepatitis & coagulopathy.
Patient started with chills and fever, started 7pm Thursday 9.20.12. Noted the area was swollen and red and felt hot/warm to the touch on 9/20 in the PM. Went to see MD on 9/21 and blood work was done for infection. Cellulitis was diagnoses.
Fever 100.9  approximately 12 hours after injection, body aches, fatigue
Pt was reported to be "anxious and nervous" about receiving her first dose of Moderna vaccine "all day" by her husband.  Pt c/o feeling nauseous 10 minutes after receiving vaccine and vomiting once in restroom after completing the required 15 minute observation period at vaccine site.  Pt walked back into POD to be evaluated by writer (clinical lead), pt reported a headache after vomiting, denied any blood in her vomit.   Denied any dizziness, chest pain, fever, chills, difficulty breathing, rashes, itching, difficulty speaking or swallowing, abdominal pain, weakness, numbness, tingling, or diarrhea.  Pt was given water and evaluated by writer (clinical lead at site, and co-leads) and observed for and additional 30 minutes while obtaining history.  Pt tolerated water PO and did not vomit in the presence of writer.  Vital signs were stable and pt reported feeling "better".  Physical exam was unremarkable: lungs clear, no increased work of breathing or accessory muscle use noted, airway patent, no facial, lip, or tongue swelling noted, no rashes observed, and abdomen soft and non-tender. Pt was discharged home from vaccine POD after evaluation completed.  No additional vomiting or new symptoms were reported by pt or husband while still on the vaccine POD premises.  Instructions provided to pt were to remain hydrated with clear liquids, advance to BRAT diet as tolerated, and pt instructed to go to ER if any new symptoms arise or anything worsens.  Pt and family member emphasized understanding, and all questions were answered.
Patient has experienced a headache since receiving the vaccine. Yesterday, (12/29/2020) getting sick; vomiting, diarrhea, low grade temp. Planning to go get COVID test, no fever.
Redness, swelling of site of vaccine administration - compress, MOTRIN and BENADRYL PRN as directed. Dosage confirmed with parent.
Information has been received from a pharmacy technician who stated that on 10-MAR-2014 or 11-MAR-2014 (reported as "on Monday or Tuesday") a box of ROTATEQ was "dropped off and left out". She said that the box sat at 72 F for at least 72 hours. On an unknown date a patient (age and gender not reported) received a dose of ROTATEQ (indication not reported), but the reporter stated that "it wasn't the one left out". However, her information was not specific enough to eliminate possibility that the recipient received one of the exposed ROTATEQ. No actual adverse event involved. Additional information is not expected.
; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could have been administered to patient), PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines stored in the refrigerator that underwent several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 49-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.         For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (vaccine that underwent temperature excursions could have been administered to patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (vaccines stored in the refrigerator that underwent several temperature excursions).    Patient received vaccine in deltoid.  No concomitant product reported by the reporter.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. No adverse reactions reported for the patient. Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion.  No treatment medication reported by the reporter.
pt recv vax 11DEC96 & 14APR97 pt devel a mild case of chickenpox;dx of varicella was made on 15APR97;
high fever, small sz, high pitched crying;hospitalized 5 days 11OCT95 to 17OCT95
Pfizer-BioNTech COVID-19 Vaccine EUA  numbness in left arm and hand post injection
headache; nausea; felt pressure in ears; swollen tongue; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the arm right on 10Mar2021 at 15:30(at the age of 43-years-old) as a single dose for COVID-19 immunization. Medical history included prolactinoma. Patient had allergy to sulfa and codine. Concomitant medications included norethisterone (NORETHINDRONE) .35mg tablet and cabergoline 1/2  (MANUFACTURER UNKNOWN) all used for unknown indication and from an unknown date. 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 10Mar2021 at 15:30 ,within ten minutes of vaccination the patient experienced swollen tongue. She was able to breathe but noticed the increase in swelling of her tongue. On 10Mar2021 at 18:30 the patient experienced headache, nausea and felt pressure in ears. The patient did not receive any treatment for the event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse event. The clinical outcome of headache, nausea, felt pressure in ears and swollen tongue were recovered.   No follow-up attempts are needed. No further information is expected.
Kinrix pfs given on 4/2 Instead of infanrix; Kinrix pfs given on 4/2 Instead of infanrix; This case was reported by a other health professional via sales rep and described the occurrence of wrong vaccine administered in a 21-month-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd April 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 2nd April 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported but could be 20 or 21 months old. The patient received Kinrix instead of Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. No side effects were reported. The reporter had asked for the date of birth of the patient and further additional information but had not got any updates. The reporter did not consent to follow up.
Injection site rash and swelling (left arm). Dx of shingles around right eye the day after vaccine given. Seen at walk in. They referred to Dr.
Patient received the vaccine on 1-25-2021. She noticed a red and itchy rash on 1-29-2021 at the injection site and all across her back.
Sore arm; Very lethargic 24 hours after injection; Tired; no appetite; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 5 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 16:15 (Batch/Lot number: unknown) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Food allergies" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "egg allergy" (unspecified if ongoing); "tree nuts allergy" (unspecified if ongoing); "sesame allergy" (unspecified if ongoing); "garlic allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Nov2021 15:00, outcome "recovered" (2021), described as "Sore arm"; LETHARGY (non-serious) with onset 06Nov2021 15:00, outcome "recovered" (2021), described as "Very lethargic 24 hours after injection"; FATIGUE (non-serious) with onset 06Nov2021 15:00, outcome "recovered" (2021), described as "Tired"; DECREASED APPETITE (non-serious) with onset 06Nov2021 15:00, outcome "recovered" (2021), described as "no appetite". Therapeutic measures were not taken as a result of pain in extremity, lethargy, fatigue, decreased appetite.  Additional information: Patient did not receive other vaccine in four weeks and other medications in two weeks. Patient did not receive covid prior vaccination and covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
headache for a few hours after injection, mild nausea, constipation starting 1/8/2021 and still continuing
Onset of fever 6pm 1/10/12 to 102.7 ax. Slightly lethargic, fussy. Acetaminophen given. Fever decreased, fussiness decreased. Fever returned at 4 hours. Highest fever 103.3 ax. Fevers on and off through 1-16-12. Throughout all 6 days took breast feeding well with decreased solid food intake. Acetaminophen only treatment.
Febrile, 18 hour's duration; and joint pain, 48 hours duration
I had a severe menstrual cramps and had to go the emergency room on Tuesday from the booster I received.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Dec2022 at 15:00 as dose number unknown (booster), single (Lot number: GJ6796), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose Number Unknown (Booster), Manufacturer Unknown), for COVID-19 Immunization.The following information was reported: DYSMENORRHOEA (non-serious) with onset 04Dec2022 at 09 :00, outcome "recovering", described as "I had a severe menstrual cramps and had to go the emergency room on Tuesday from the booster I received.". The events "i had a severe menstrual cramps and had to go the emergency room on tuesday from the booster i received." required emergency room visit. Therapeutic measures were taken as a result of dysmenorrhoea.  Additional information: Patient had not been received any other vaccine within four weeks and other medication within two weeks. Medication to help with the excruciating pain. Patient not had Covid prior vaccination and not been tested post vaccination.
Pt seen in office 11/7/02 with mild out break of varicella.
This spontaneous report as received from a male consumer of unknown age refers to himself. On 16-AUG-2010 the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route unspecified). On 08-APR-2014, the patient was diagnosed with shingles on 08-APR-2014. He reported that he developed a rash on the center of his chest that wrapped around his right side to his spine. He stated that he was seen by a dermatologist on 08-APR-2014 who took "scrapings" of his rash. He reported that the result of the "scrapings" showed tha the had shingles. He stated that he was placed on VALTREX for 7 days and was also prescribed ibuprofen 800mg 2 or 3 times per day for pain. He reported that after he finished the VALTREX, he still had "discomfott" and went to see his primary care physician "2-3 weeks later". He stated that his primary care physcian prescribed him an unspecified steroid. He reported that he was recovering and only got an itching sensation in his back "every so often". This is one of several reports received from same source. Additional information has been requested.
Penis grew larger by 5 times approximately 5 days after I received the first dose of the Pfizer vaccine. I can now no longer put my pants on and must wear large athletic shorts to attend class. Please help.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and on 16Dec2021 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.   No follow-up attempts are possible. No further information is expected.
Initial report received on 12/04/06 from a health care professional. A male pt, with no concurrent illnesses, had received a dose of Adacel, on 1/10/06. The lot number, route and site of administration were unk. A some point after receipt of Adacel, the pt was hospitalized and diagnosed with Guillain Barre syndrome. The pt was paralyzed from the waist down. he received rehabilitation therapy, and at the time of this report, the pt had fully recovered. Treatments received, and diagnostic test performed were not reported.  12/21/06 Received medical records from PCP which reveal patient received DT on 1/10/06 & note indicates healthy at that time.  Next note is for 11/21/06 which reveals patient had resolving GBS.  2/26/07 Received medical records from hospital which reveal patient admitted 3/06//06-4/14/06 after experiencing a several week history of progressive neck & back pain & muscle weakness.  Condition continued to worsen after admission.  Treated w/IVIG , plasmapheresis & steroids  During hospitalization developed ascending paralysis from feet to ocular muscles.  No respiratory compromise.  Neuro consult, PT/OT provided & transferred to inpatient rehab facility then to home with 24 hour care & home health PT then to day rehab program.  When d/c from inpatient rehab patient was max assist with rolling & assist to sit.  Was w/c bound w/RUE weakness.   FINAL DX: acute demyelinating polyneuropathy, most likely GBS; nypercholesterolemia.  7/21/09 Medical record received DOS 1/10/06 to 2/5/06. Onset of paralysis on 2/5/06. Still trouble climbing stairs in Nov.'06.
Severe pain in arm.   Fever.  Headache.  Nausea.  Tingling in hands.  Vomiting
Bad headache, worse than typical headache, lasted several days and associated with nausea.  Also experienced a red welt at the injection site.
This spontaneous report as received from a health care worker refers to a patient of unknown demographics. On 23-OCT-2013, the patient was vaccinated with unsupported dose of MMR II (lot number J000201 and expiry date 09-JAN-2015). No concomitant therapy was administered. No adverse effects reported. This report is one of the four patients reported from same source. This case is linked to 1311USA008915, 1311USA008914 and 1311USA008744 (same reporter link). Additional information has been requested.
MOTHER IS A NURSE PRACTITIONER AND REQUESTED A VAERS BE COMPLETED ON HER CHILD.STATES THE MORNING OF 11/9/7  LYMP GLANDS OF LT ARM PIT SWOLLEN AND LARGE AMT OF REDDNESS AND   SWELLING.STATES HE RAN A FEVER OF 103 FOR 3 DAYS.CLIENT DID CALL THE CHILD MD BUT CHILD NOT SEEN BY A MD.MOTHER DESCRIBED REDDENESS AS 10-12CM SIZE AND SWELLING DOUBLE THE SIZE OF HIS ARM
menstrual spotting on 06May2021 and still happening; like heavy menstrual cramps; only site pain like soreness; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (menstrual spotting on 06May2021 and still happening), DYSMENORRHOEA (like heavy menstrual cramps) and VACCINATION SITE PAIN (only site pain like soreness) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy, Seasonal allergy and Penicillin allergy. Concomitant products included ESCITALOPRAM for Antidepressant drug level.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PAIN (only site pain like soreness). On 05-May-2021, the patient experienced INTERMENSTRUAL BLEEDING (menstrual spotting on 06May2021 and still happening) and DYSMENORRHOEA (like heavy menstrual cramps). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INTERMENSTRUAL BLEEDING (menstrual spotting on 06May2021 and still happening), DYSMENORRHOEA (like heavy menstrual cramps) and VACCINATION SITE PAIN (only site pain like soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication with birth control pill was reported by the patient . Treatment with Ibuprofen was reported by the reporter.
This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient were vaccinated with two doses of ROTATEQ (strength, dose, frequency and route were not reported) lot # K023535 with an expiry date of 22-MAY-2016. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the two reports received from the same reporter. Additional information has been requested.