chrisvoncsefalvay/vaers-outcomes huggingface dataset:
granuloma skin bumps; Bump at Permanent injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: EN6205) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE MASS (non-serious) with onset 19Mar2021, outcome "unknown", described as "Bump at Permanent injection site"; GRANULOMA SKIN (medically significant), outcome "not recovered", described as "granuloma skin bumps". The event "granuloma skin bumps" required physician office visit. Therapeutic measures were taken as a result of granuloma skin with Biopsy/Steroids. Therapeutic measures were not taken as a result of vaccination site mass.  Additional information: The bump was 1/4", not serious. Patient did get covid after 3rd dose but symptoms mild + clear test after a week.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148992 same patient, different dose/AE;
chills and shivering, following by waking in the night in a cold sweat disoriented, confused, and upset
Info has been received from a health professional, through a mfr pregnancy registry, concerning a 26 year old white female tobacco user with no known drug allergies and a history of 3 previous pregnancies with 3 full-term births who on 6/8/04 and 7/9/04 was vaccinated, SC, with the 1st and second 0.5 ml doses, respectively, of varicella virus vaccine live. There was no concomitant therapy. The health professional reported that after the 2nd dose was administered, the pt thought she may have been pregnant. Unspecified medical attention was sought and a pregnancy test was administered which was (+). On 2/25/05, at 38 weeks gestation, the pt gave birth, vaginally, to a well male weighting 6 lbs 12 oz. The infant was normal and no congenital anomalies, complications or abnormalities were noted. The mother and infant did not have any adverse events. Follow-up info indicated that on 4/8/05, the infant developed congestion, a cough and green snot. On 4/15/05, a dx of upper respiratory tract infection was made. On 4/20/05, the infant's cough persisted coupled with eye drainage and nasal crusting. He was noted to be afebrile. At the time, it was felt that the infant was still suffering from a viral URI. Subsequently, the pt's viral URI resolved. No further info is available.
Soon after vaccination arm began to feel hot. Within 24 hours arm swelled up along with intense pain that was felt from upper arm to fingertips. Swelling resolved after 4 days. Pain continues periodically in upper arm. Has history of reaction to preservatives.
16 hours after dose 2 headache/Mild headache for two days.; chills; 99.9 F fever; tired; This is a spontaneous report from a contactable consumer or other non-Health care professional. A 51-years-old female patient received bnt162b2 (BNT162B2, solution for injection, lot number was not reported, expiry date was not reported), dose 2 via an unspecified route of administration on Apr2021 (Age at vaccination-51 years) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2, solution for injection, dose 1 via an unspecified route of administration on Apr2021 at the age of 51-year-old as dose 1 single for Covid-19 immunization with reaction Tired and had Injection site soreness. On Apr2021 the patient experienced 16 hours after dose 2 headache/mild headache for two days, chills, 99.9 F fever, tired. On Apr2021 the patient underwent lab tests and procedures which included body temperature was 99.9 fahrenheit. Patient was not hospitalized. Seriousness as no. The patient had received any other vaccine within 4 weeks was unknown. Patient had not been diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination was unknown. The clinical outcome of the events was recovered on unspecified date Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient given undiluted dose. Patient did not have any major side effects. Just some fatigue the following day. Patient advised if becomes symptomatic at all to contact office with symptoms.
slight fever; a slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever) and HEADACHE (a slight headache) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PYREXIA (slight fever) and HEADACHE (a slight headache). At the time of the report, PYREXIA (slight fever) and HEADACHE (a slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was provided by the reporter  as blood pressure medicine.  Treatment information was not provided.
Itchy red spots on hands, thigh, under breast and itching all over body-comes and goes; Itchy red spots on hands, thigh, under breast and itching all over body; swells up; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy red spots on hands, thigh, under breast and itching all over body-comes and goes), ERYTHEMA (Itchy red spots on hands, thigh, under breast and itching all over body) and SWELLING (swells up) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PRURITUS (Itchy red spots on hands, thigh, under breast and itching all over body-comes and goes), ERYTHEMA (Itchy red spots on hands, thigh, under breast and itching all over body) and SWELLING (swells up). The patient was treated with HYDROXYZINE at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itchy red spots on hands, thigh, under breast and itching all over body-comes and goes), ERYTHEMA (Itchy red spots on hands, thigh, under breast and itching all over body) and SWELLING (swells up) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication information was provided.  Zyrtec was given as treatment medications with instructions to take for 1 month and then stop to see if it has improved and continue if there was no improvement in symptoms. Patient stated since she has been taking  Zyrtec her hands aren't as bad however but she continued to develop red itchy spots,has one on her thigh and under her breast now.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Added Treatment medications and additional event (swells up).
87 yo male with history of COPD, HTN, past MI and lung cancer. Shortly after administration of flu vaccine, patient was in waiting room awaiting doctor's visit and was noted to be drowsy. Pt reported feeling lightheaded, dizzy. Patient began to slide down in chair so was lowered to the floor with assistance of staff. Patient awakened on the floor and stated I do not know how I go to the floor. VS: 168/79 HT 82 O2 sat 97% 2 l/m NC applied, RR 16. Patient assisted to stretcher gently by 4 staff members/safely. Patient awake/hrr/spont resp continue. Patient transferred via EMS to local hospital for evaluation of syncopal event. Outside hospital records show CT Head was done with no acute findings, noted cerebral atrophy and evidence of chronic microvascular ischemic changes. EKG normal. Patient's symptoms quickly improved. Pt reported to ED physician that he has had similar episodes in the past. Upon review of his chart, he does have a history of syncopal episodes (not noted to be related to vaccine administration) and has been worked up for this. Of note, he received flu vaccine last season without any adverse effect.
12/16/06 21:45 Subject taken to ER for lung congestion and fever. WBC 12.2 other labs WNL, Chest x-ray perihilar congestion due to recent URI or bronchitis. RSV negative, NKDA. Discharge home after ER observation at 7:50 hours.
Immediately felt dizzy and nauseous.   Ci to used to be extremely dizzy and nauseous for 5 days after shot. Now have slight fever and rash on face.
Pt developed localized red rash around injection site. Became more red and warm after 2 days post-immunization. Rash was approx size of golf ball. Was told to monitor size of rash.
Severe burning sensation in mid-abdominal, nausea, chronic diarrhea every 2-3 day since 1st dose and daily since 2nd dose on 09Jan2021; Severe burning sensation in mid-abdominal, nausea, chronic diarrhea every 2-3 day since 1st dose and daily since 2nd dose on 09Jan2021; Severe burning sensation in mid-abdominal, nausea, chronic diarrhea every 2-3 day since 1st dose and daily since 2nd dose on 09Jan2021; This is a spontaneous report from a contactable other HCP (patient). A 50-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730; expiration date not provided), intramuscular (anatomical location: arm left) on 19Dec2020 at single dose, then second dose intramuscular (anatomical location: not provided) on 09Jan2021 (lot number and expiration date not provided) at single dose for COVID-19 immunisation. Patient is not pregnant. Medical history was reported as none. Concomitant medications included sumatriptan, escitalopram oxalate (LEXAPRO), and ascorbic acid, betacarotene, biotin, capsicum annuum fruit, colecalciferol, collagen marine, curcuma longa, cysteine hydrochloride, equisetum arvense, fallopia japonica, hyaluronic acid, iodine, keratin, lysine, methionine, piper nigrum, selenium, serenoa repens, tocotrienols nos, withania somnifera, zinc (NUTRAFOL), also reported as Woman's Balance. The patient did not receive other vaccine in four weeks. The patient has no known allergies. The patient has no COVID prior vaccination. On 27Dec2020, the patient experienced severe burning sensation in mid-abdominal, nausea, and chronic diarrhea every 2-3 day since 1st dose and daily since 2nd dose on 09Jan2021. It was reported that the events resulted in doctor or other healthcare professional office/clinic visit. It was reported that patient received anti-nausea prescription and loperamide (IMODIUM AD) as treatment for the events. Patient was not COVID tested post vaccination. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Area on arm where received shot is swollen with hard lump and red circle and warm to touch.
Pt. stated she felt her arm about 5 days ago and felt a small lump where 1st vaccine was given.  She stated she did not know it was there until she touched it.  She also stated it is tender to touch only.  No redness or heat visualized by nurse today and lump is about the size of a small marble.  Instructed pt. to apply a warm compress a few times a day and to follow up with PMD if worsens.  She received second MMR today as scheduled.
An MA gave this patient an concentrated covid vaccine without diluting it 0.3 mL of the pfizer covid vaccine. As soon as this nurse realized what had occurred this nurse informed MA and the manager. Patient was just finished with lab and was taken to a patient room for evaluation. As manager was calling infection disease to see what guidelines needed to be followed MA and this nurse evaluated patient.They informed us to assess the patient for 30 minutes in the clinic and call Pfizer for next steps. Patient was informed of the situation and stated she felt fine was was now anxious due to the situation. This nurse will document the timeline of vital below. 1135 injection given by MA 1148 BP 190/80, HR 78, 99% oxygen 1154 BP 172/70, HR 63, 98% oxygen temp 97.9 1156 Patient felt a warm feeling up the right arm(injection site arm) 1204 warm feeling was absent 1205 BP 174/80, HR 74, 98% 1210 Patient states she felt fine but still a little anxious 1217 Assessment preformed by APRN 1239 BP 160/70. Patient has history of being anxious and having a high blood pressure in medical facilities. Pt was informed of S/S and if chest pain or any heart issues that are severe to go to the ER. Pfizer informed RN that if it was not diluented to not repeat dose, a study had shown that 100 mcg was not harmful, local reaction may occur, and that the arm was painful. The patient was informed of all information. Pt verbalized understanding and will let us know if her blood pressure does not decrease when relaxed at home. Pt was doing well at this time, being an hour after injection patient left clinic.
Information has been received from a pharmacist, via a company rep, concerning a female (age unk) who in Apr 2006, was vaccinated (route unk) with a dose of pneumococcal 23v polysaccharide vaccine (lot unk). It was reported that after receiving a dose of pneumococcal 23v polysaccharide vaccine the pt had to be admitted to the hospital because of a fever. The fever developed within 23 hrs of receiving the vaccine. It was reported that the pt had a low grade fever before vaccination and she was being observed in a hospital setting for an upper respiratory condition and during this observation was when the pneumococcal 23v polysaccharide vaccine was administered. It is not clear if the fever was from the vaccination of the pre-existing respiratory condition. No product quality complaint was involved. Additional information has been requested.
Throbbing Headache: 3rd dose, started on day 2 muscle aches 2nd dose: started 4 hours later lasted 5 days Muscle aches 3rd dose/booster: started 12 hours later cold sweats 2nd dose: started 4 hours later lasted 4 days Cold sweats 3rd dose/booster: started 24 hours later sharp lower abdominal pain: 3rd dose started 10 hours later nausea, sore arm: 2nd and 3rd dose lasted 20 hours
Patient received a 2nd bivalent formulation inadvertently. No previous monovalent doses. No anaphylactic signs or reactions after administration.
psoriasis flare up (psoriasis spot on arms and leg); covid vaccine issue like injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (psoriasis flare up (psoriasis spot on arms and leg)) and VACCINATION SITE PAIN (covid vaccine issue like injection site pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (psoriasis flare up (psoriasis spot on arms and leg)) and VACCINATION SITE PAIN (covid vaccine issue like injection site pain). At the time of the report, PSORIASIS (psoriasis flare up (psoriasis spot on arms and leg)) and VACCINATION SITE PAIN (covid vaccine issue like injection site pain) outcome was unknown.            No Concomitant medications were reported. No treatment medications were 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.
Received vacc. in the am. Devel nausea at 10 pm -> dizziness slowly devel chills -> headache very intense (8/20) stiff neck and soreness, headache lasted whole night, next day he was fine!! but weak, then 7 pm had chills and body ache and fatigue and headache with sweating and stiff neck, went to ER. Noted done. Next day was weak then got 100% better.
Sore Arm.  Began 02/03/2021, ended 02/05/2021. Fever, ranging from 99.2 --  101.9.  Began 02/06/2021, ended 02/08/2021. Sore Throat.  Began 02/06/2021, ended 02/08/2021. Headache.  Began 02/07/2021, ended 02/09/2021.
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 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Sep2022 at 13:15 as dose 1, single (Batch/Lot number: unknown), in left 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 Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: On 16Dec2022 the patient was treated with Paxlovid for treatment of COVID-19  and Date of last administration was on 17Dec2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Delayed rash around injection site appearing over a week after 1st dose. Rash is raised but doesn?t itch. Occasionally some pain running down the arm.
Headache, body aches, chills, dizziness,  soreness and swelling at injection site
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 23-AUG-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N030174 and expiration date 13-JUN-2019) orally for prophylaxis. The MERCK STERILE DILUENT (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
Case previously recorded as MA2009-3480. Initial case report received from a consumer via MedCom on 30 OCT 2009. A female patient of unknown age was vaccinated with an influenza pandemic INN vaccine (batch no. unknown) on 30 OCT 2009. The patient was vaccinated subcutaneously. Thus, this vaccination was performed with an incorrect route of drug administration. MedCom reference no.: NA09-007330.
91 year old female was sitting across the table from her husband while eating lunch when she passed out.  She had slurred speech.  911 was called.  She was taken to the ER and was diagnose with acute stroke.  Her symptoms subsided on presentation to the ER.  She was started on Plavix.  Had negagive carotid duplex. MRI brain showed suspected subtle nonhemorrhagic punctuate left frontal lobe, Cortical 2-3mm acute -subacute vascular insult vs image artifact.
SWEATING, INCREASED HEART RATE, INCREASED BLOOD PRESSURE, INCREASED BODY TEMPERATURE
prostatitis/prostatitis spread throughout his body in an infection; left shoulder was still hurting; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATITIS (prostatitis/prostatitis spread throughout his body in an infection) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PROSTATITIS (prostatitis/prostatitis spread throughout his body in an infection) (seriousness criterion hospitalization) and ARTHRALGIA (left shoulder was still hurting). At the time of the report, PROSTATITIS (prostatitis/prostatitis spread throughout his body in an infection) and ARTHRALGIA (left shoulder was still hurting) had not resolved.            No concomitant and treatment information was provided. It was reported that the patient's left shoulder was still hurting since he got the second shot. Patient ended up 2 weeks later getting prostatitis and never went away. Patient ended up in hospital. It came back and got spread throughout his body in an infection which was still present.  Company Comment: This case concerns a 60-year-old, male patient, with no known medical history, who experienced the serious, unexpected event of prostatitis and non-serious expected event of arthralgia. The events occurred  on unknown date after second dose of mRNA 1273 vaccine. The rechallenge is not applicable as there is event prostatitis is still on going. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 60-year-old, male patient, with no known medical history, who experienced the serious, unexpected event of prostatitis and non-serious expected event of arthralgia. The events occurred  on unknown date after second dose of mRNA 1273 vaccine. The rechallenge is not applicable as there is event prostatitis is still on going. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Patient received his Pfizer Covid19 booster vaccine.  He was with his parents walking down one of the aisles in the store, shortly after receiving the vaccine, and he fainted.  Parents thought he might be having a seizure.  Paramedics were called.  He was taken to the hospital.  His father was contacted the following day by the pharmacy department and we were told the patient did not have a seizure but had vasovagal syncope.  He was given fluids at the hospital and monitored.  Father said patient is doing good today.