chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19 vaccination injection site became red; COVID-19 vaccination injection site became hard; COVID-19 vaccination injection site increased in swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (COVID-19 vaccination injection site became red), VACCINATION SITE ERYTHEMA (COVID-19 vaccination injection site became hard) and VACCINATION SITE SWELLING (COVID-19 vaccination injection site increased in swelling) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) injection for Plaque psoriasis and Psoriatic arthritis.    Concurrent medical conditions included Plaque psoriasis and Psoriatic arthritis.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Dec-2021, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram once a day. On 31-Jan-2022, RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) dosage was changed to 150 milligram every three months. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2022, the patient experienced VACCINATION SITE INDURATION (COVID-19 vaccination injection site became red), VACCINATION SITE ERYTHEMA (COVID-19 vaccination injection site became hard) and VACCINATION SITE SWELLING (COVID-19 vaccination injection site increased in swelling). At the time of the report, VACCINATION SITE INDURATION (COVID-19 vaccination injection site became red), VACCINATION SITE ERYTHEMA (COVID-19 vaccination injection site became hard) and VACCINATION SITE SWELLING (COVID-19 vaccination injection site increased in swelling) was resolving.            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.  No concomitant medication was reported.  The patient experienced the events over a three days period till it was softball sized on patients arm. It stopped getting bigger on 16-Apr-2022 and was not currently back to normal skin color and size.  It was unknown if patient was enrolled in a COVID-19 vaccine trial. The primary reporter did not have the lot number information, because the packaging was discarded.  No treatment medication was reported.  The reporter's causality for the event(s) of COVID 19 vaccination injection site became red, hard and increased in swelling onset 13 Apr 2022, COVID 19 vaccination injection site became red, hard and increased in swelling onset 13 Apr 2022 and COVID 19 vaccination injection site became red, hard and increased in swelling onset 13 Apr 2022 was not provided for co-suspect Skyrizi.
TESTED POSITIVE for COVID-19 after 5 vaccinations. Tested positive for COVID-19 (At-Home BD Veritor COVID-19 Test) on November 5, 2022 with mild symptoms (runny nose). On November 7, symptoms grew worse with severe sore throat Started prescription of Paxlovid on November 8 with quickly reduced severity of my illness. By November 11, I was feeling nearly normal and essentially no symptoms, however tested positive with At-Home BD Veritor COVID-19 Test On November 14 continued to test positive. On November 15 tested negative and had no symptoms.
Information has been received from a physician via a company representative referring to an unspecified number of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug allergies/reactions were not reported. On unknown dates, the patients were vaccinated with two doses of PNEUMOVAX 23 (Lot#, dose and route were unknown) for prophylaxis in less than the five year recommended spacing. No adverse effects were reported. Additional information is not expected as there is no consent to contact the reporter.
PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENT, THIS IS A REPORT FOR AN ADMINISTRATION ERROR.  PATIENT RECEIVED FIRST DOSE OF VACCINE ON APRIL 23, 2021 AND SECOND DOSE ON 5/6/2021.  AT CLINIC, PATIENT DID NOT HAVE CARD AND NAME GIVEN ON CONSENT FORM DID NOT MATCH ENTRY INTO SYSTEM
Hot to touch swollen hard lump that grew over 2 days to three times the size.
This spontaneous report as received from a physician refers to a patient of unknown age. On 02-OCT-2012, the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # 666029/1456Y, expiration date 06-AUG-2012) (dose, route not reported). No other co-suspects were reported. No concomitant medications were reported. No symptoms reported. Additional information has been requested.
Rash--progressed to hives and shaking body movements felt to be a seizure per parent--not suppressable. Last approx. 1 minute while child "asleep" in crib.
Massive headache, fever, shivers, body aches, nauseous, sleepy. On onset, just sick feeling - laid down, and started feeling worse. Symptoms similar to flu - fever of 102, face hot, rest of body cold, nauseous, massive headache (all around my head)  could not comfortably lay on head, body aches (besides at sight of injection. Very sleepy, slept most of day.
25JAN93 mom said pt had high pitched cry x 3 days; p/1st vax pt cry very differnet than usual; could not comfort pt;
headache; sore right arm; This is a spontaneous report from a contactable consumer (patient self-reported) in response to non-HCP follow-up letter sent in cross reference case. A 72-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown), via an unspecified route of administration, on 22Feb2021, as single dose for COVID-19 immunisation. Patient's historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264 and expiry dates: unknown), via an unspecified route of administration, on 29Jan2021 as single dose for COVID-19 immunisation. Patient concomitant medications included from 1983 she taking estrogens conjugated (PREMARIN) still ongoing. which she took due to surgery at an early age and had migraines without it, from year2000 Acetylsalicylic acid (COATED ASPIRIN) still ongoing, Lisinopril started from year2000 and still ongoing, Zinc, Vitamin D3, Ascorbic Acid (VITAMIN C) started from Mar2020 and still ongoing. Patient medical history included which was surgery at an early age. The patient took the second dose of Pfizer COVID Vaccine on 22FEB2021 which only caused headache and a sore right arm which lasted about 24 hours on unspecified date. Patient received Benadryl and Tylenol as treatment. The outcome of the event was recovered on an unknown date.  Follow-up (02Apr2021): This is a follow-up spontaneous report from a contactable consumer. This 72-year-old female consumer reported in response to non-HCP follow-up letter sent in cross reference case that included.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained.
Left arm with 2x2 inch knot noted that is red. No warmth noted or signs of infections. Pt seen was office on 3/14/2019 and evaluated by MD. MD instructed patient to do symptomatic treatment only.
while waiting in observation area, patient complained of feeling lightheaded.  The patient was taken to the nurse observation area.  Vital signs were recorded and reported to the doctor.  All vital signs were within normal limits.  The patient's only complaint was lightheadedness which lasted about 30 minutes .   The patient was discharged home with her husband.  She was able to ambulate on her own and denied any other symptoms.
This case was reported by a healthcare professional and described the occurrence of abdominal swelling in a 29-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). The subject's medical history included blood transfusion. On 13 April 2011 the subject received 1st dose of ENGERIX B (.5 ml, intramuscular, left arm). On 13 April 2011, less than one day after vaccination with ENGERIX B, the subject experienced abdominal swelling, injection site redness, injection site tenderness, intermittent fever, swollen liver and vaccine underdose (adult dose of ENGERIX B is 1 ml). The reason for the vaccine underdose was not reported. A healthcare professional visit on 13 April 2011 noted swelling around the liver. The subject was hospitalised and the healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting, the injection site redness and injection site tenderness were improved, the intermittent fever was unresolved, and the outcome of the abdominal swelling and swollen liver was unspecified. The vaccination course with ENGERIX B was discontinued. The healthcare professional considered the injection site redness and injection site tenderness were probably related to vaccination with ENGERIX B, the abdominal  swelling was possibly related to vaccination with ENGERIX B, and the relationship of the intermittent fever and swollen liver was unspecified.
Patient states that the flu shot reulted in her shoulder being frozen and her rotator cuff being torn, although this is impossible the 5/8 inch needle could not have reached her rotator cuff, proper technique was observed, and even if the cuff had been penetrated by a needle it would not have resulted in an injury
Redness at injection site. She's been using ice packs, IBUP for fever and starting BENADRYL. Spoke to her Dr and they said to continue this treatment.
Pt extremely pale, diaphoretic, lightheaded. AAOx3. Respect even and unlabored. Reports extensive hx of this rection to medical procedures. With lying down began to gain color in face, less diaphoresis, and lightheadedness. Instructed to request lying down for 2nd vaccine. Left walking without s/s of distress. BP stable 132/82, spO2 97%, HR 70.
Pt had fever of 101f and red streak from vaccine site about 6-8 inches down arm. Pt went to doctor to see if she had covid. Dr thought she had infection and prescribed 2 antibiotics including amoxicillin and benadryl. Red streak became more topically inflamed and warm with more swollen lymph nodes per patient assessment. Pt called pharmacy to report. Pharmacist filed vaers and referred pt to primary provider.
Blood pressure dropped to 75/45; This is a spontaneous report from a contactable consumer (Patient, reported for self).  A 63-Years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot number: Ew0187; Expiration date: UNKNOWN), via an unspecified route of administration, administered in left arm on 25May2021 at 15:45 (at 63-Years-old) as single dose for COVID-19 immunization. Patient medical history included lupus (Name of Drug as Reported :No) from an unspecified date and unspecified if ongoing. Patient was diagnosed positive with COVID prior to vaccination on an unspecified date. Patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   Reaction/event as reported by primary source: On 28May2021 at 12:00, Blood pressure dropped to 75/45 on the 3rd after shot. stayed that low most of the 3rd day. Came back up on the 4th day. The patient was not tested for COVID-19 since the vaccination. The patient underwent lab tests and procedures which included Blood pressure measurement of 75/45 (units not reported) on 28May2021. No Hospitalization Prolonged. The outcome of event was recovered on 29May2021.   Information on Lot/Batch number was available. Additional information has been requested
No additional clarifying statements or AE details were provided and no additional AE's were reported.; The HCP reports that a patient received their first dose of GARDASIL on 25JUL2011 and then didn't receive their second dose of GARDASIL until 23MAY2012.; This spontaneous report was received from a nurse referring to a 19-year-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not applicable.  On 25-JUL-2011, the patient was vaccinated with the first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, 0.5ml, lot #0992Z, expiration date: 14-OCT-2012, administered intramuscularly for prophylaxis (strength was not provided). On 23-MAY-2012, the patient was vaccinated with the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, 0.5ml, lot #0022AE, expiration date: 28-SEP-2014, administered intramuscularly for prophylaxis (strength was not provided) (inappropriate schedule of product administration). The patient never received her third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). No additional clarifying statements or adverse event (AE) details were provided and no additional AEs were reported (no adverse event).
Information has been received from a health professional concerning a 12 year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 30-Mar-2007, the patient was diagnosed with chickenpox. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. This is one of several from same source. Additional information is expected.
A report was received from a health care professional on 11/19/03 concerning a 50 year old female vaccinee who experienced a localized red wheal at the injection site which was raised and warm to touch 1 day after receiving Fluvirin on 11/18/03. On 11/19/03, the vaccinee experienced a localized red wheal at the injection site, which was a nickel to half a dollar in size, raised and warm to the touch. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporters causality assessment. Follow up pending.
12/29/21 presents to antepartum for "generalized body aches and bilateral hip pain, cough, diarrhea". PMHx of "Sickle cell disease, avascular necrosis of bones of both hips, marijuana use, obesity, 31 weeks and 6 days pregnant"
I was fine following the shot.  But when I awoke the next day, I felt Dehydrated, with a headache, and feeling exhausted, much like a hangover, but I had no alcohol in several days.  I kept hydrating myself throughout the day but was not able to concentrate on work very well.  Ended up taking Ibuprophin at my Wife's (nurse's) urging, around 3:00 PM.  Headache alleviated for the most part after but still felt exhausted until I went to bed.  I awoke fine on 3/12/21.
Patient sent to ER 10/08/07 with foreign body in left eye. Received Td. Seen for follow-up 9/10/07. Right deltoid slightly swollen, red, hard, warm and painful, given 600mg IBP and plan for follow-up discussed.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 2010, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-SEP-2013, the patient was treated by the same physician for a the onset of a vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and would continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The causal assessment between the aforementioned events and vaccination with ZOSTAVAX was reported as related.
Fever 101.2 for 12 hours commencing 24 hours after shot Tiredness
Pt states she developed hives all over her body, states hives are itchy and feel hot, not whole body hive coverage but random break outs of redness and hives, first started on the L hand, same side of injection, then hives randomly appearing behinds knees, chest, bilateral flank, ankles, pt is taking Benadryl with temp relief, also using antihistamine cream.
This case was reported by a healthcare professional via sales representative and described the occurrence of decreased therapeutic response in an unspecified number of subject of unspecified ages and gender who were vaccinated with ENGERIX B (GlaxoSmithKline). On unspecified dates the subjects received unspecified doses of ENGERIX B (40 mcg, unknown). At unspecified times after vaccinations with ENGERIX B, the subjects experienced decreased therapeutic response. The healthcare professional reported the after administering the 40 mcg dose of ENGERIX B for the dialysis center's subjects, 60 to 70 percent of the subjects have to be revaccinated due to low titer levels. No subject specific details were available. At the time of the report, no other information was available.
A spontaneous report has been received from a consumer concerning a Caucasian male patient of (age 44 years 49 weeks 5 days, height 67 in, weight 170 lb). No medical history was reported. The following demography was reported for the patient's parent: Sex: Unknown Concomitant medication included cetirizine hydrochloride for allergies. The patient received FLUMIST QUADRIVALENT  (intranasal) (batch number Unk) 0.25 ml once/single administration (preferred term: Off label use), via nasal route, for flu vaccine on 01-OCT-2018. Patient stated on 02-Oct-2018, when he woke up, he had a really runny or significantly runny nose, he took antihistamine, Zyrtec which seemed to make it go away and most of 02-Oct-2018, he had a dry cough (preferred term: Cough) that was more than typical but he was recovering and also his nose was stuffed up but seemed to be only slight at the time of report (recovering). HCP not aware. The outcome of the event of received 0.25 ml FLUMIST QUADRIVALENT (off label use) was unknown. The events were considered non-serious.
Fever; Muscle ache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Muscle ache) and CHILLS (Chills) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced PYREXIA (Fever), MYALGIA (Muscle ache) and CHILLS (Chills). At the time of the report, PYREXIA (Fever), MYALGIA (Muscle ache) and CHILLS (Chills) outcome was unknown. Not Provided          No concomitant medication were provided. Treatment information not provided. Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
Information has been received from a 26 year old female who was vaccinated with a third dose of Gardasil. Concomitant therapy included TRIPHASIL. On approximately 26-JUN-2007 the patient experienced pain at the injection site. On 14-JUL-2007 the patient developed a "bump" at the injection site. Subsequently, the patient recovered. It was reported that the patient had "no problems after the first two shots". Additional information has been requested.
Covid19 breakthrough.  1st vacine received on 12/28/2020.  91 y/o male with PMHx of AFIB, HTN, SAH, CAD s/p CABG, Pancreatic cancer, Biliary disease with obstruction s/p biliary stent in Sept 2021 presents to ER with c/o severe chills, uncontrollable shaking, confusion.  Temp 101.1, room air sat 99%, CXR with no acute process.  Pt with elevated WBC and CT A/P with possible obstruction of stent.  Pt planned to have EUS/ERCP.  Pre procedure Covid test +.  On IV abx.
Upper right arm had extreme pain in muscle at vaccine administration site of Pneumococcal Polysaccharide Vaccine. Unable to lay on arm when sleeping do to extreme pain for approx 8 hrs beginning 7 hrs after vaccination was given at 10 AM 10/26/2006. At approx 8 AM the next day 10/27/2006, the skin on the right arm beginning at the vaccination site proceding 3 inches wide and 7 inches down the arm was raised with red blotches that were warm to touch and itched. Application of Triamcinolone 0.1% Ointment reduced the skin swelling to onlya few red raised blotches after 12 hours as of 10 AM on 10/28/2006.
8AUG98 fatigue, neck pain;9AUG98 paresthesia rt side thigh, rt side calf & rt side flank;12AUG98 MRI spinal lesion @ C2;dx mult sclerosis; Per follow-up dated 9/11/00, the pt continues to have fatigue, numb hands-dx with MS but no new lesions since August of 1998
had another reaction; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (had another reaction) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had another reaction). At the time of the report, VACCINATION COMPLICATION (had another reaction) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  Very limited information regarding this event has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-054550 (Patient Link).; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
I had no prior uterine bleeding issues. No history of gynecological issues. I got the 1st dose of the vaccine and started having uterine bleeding. It subsided. I got the second dose and a month later the uterine bleeding restarted. Since that time, in has been an excess of daily uterine bleeding to where I've had to have a DNC which is a gynecological procedure and an IUD device placed to try and stop the bleeding. I have received medication and it continues. I'm planning in the next several months to remove my uterus to try to resolve the issue. Its daily without stopping.
On 6/22, injection site mildy sore.  On 6/23, awoke and had symptoms all day of nausea, very fatigued, fever of 100 degrees F, site with 3 to 4 cm hardened with deep erythemia, site warm to touch.  On 6/24, no systemic complaints and site is approximately 5mm in diameter and itchy.