chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She had this cold; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (She had this cold), HEADACHE (headache) and PYREXIA (fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 036A21A and 015M20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: pneumonia vaccine (Patient had hives on arm and hand after receiving the second dose of the pneumonia vaccine). Past adverse reactions to the above products included Hives with pneumonia vaccine. Concurrent medical conditions included Rheumatoid arthritis, Cardiac disorder NOS (Cardiac medication), Egg allergy (egg yolk allergy), Fruit allergy (papaya allergy), Fruit allergy (banana allergy), Allergy to nuts and Fish allergy. Concomitant products included FLECAINIDE ACETATE for Cardiac disorder NOS.   On 09-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 05-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (She had this cold), HEADACHE (headache) and PYREXIA (fever). At the time of the report, NASOPHARYNGITIS (She had this cold), HEADACHE (headache) and PYREXIA (fever) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2022, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, SARS-CoV-2 test: positive (Positive) Tested positive for Covid-19 after receiving the first two vaccines.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided by the reporter   It was reported that the patient does not t have any actual allergy but some sensitivities.She stated it was 2 weeks before the  variant hit the city and about one month ago there was a very bad cold going around her city. She had this cold and states the symptoms were pretty similar.   This case was linked to MOD-2022-542346, MOD-2022-542349, MOD-2022-542351 (Patient Link).
Erythema of the Rt upper arm, temp of 101 X 2 days, itching and pain and tender axillary Adenopathy. Pt given Keflex 500mg tby mouth QID on 04-27-09 cellulitis R deltoid.
I got the vaccine Tuesday afternoon after eating lunch Wednesday notices the arrhythmia on top of that I had the normal symptoms body ache, fatigue flu like symptoms the normal booster side effects. Most people I know had these symptoms 24-48 and mine lasted for a week. I am not sure if they have anything to do with the arrhythmias. After one week the arrhythmia and other side effects went away. I did not see a doctor.
L-arm tingling , "heaviness" - site w/o swelling redness -  + pulse.  5 mins later - midline chest tightness "uncontrollable urge to belch"  without other assoc. symptoms;   125/93  -- 95 -- 120/89  chest tightness much improved - conversing & cheerful.
Pt recvd 1st dose of Hep B vax 18FEB89 & devel fever,chills & malaise for 10 hrs.18JUL89 pt recvd 2nd vax & exp same reaction w/ soreness,redness & localized swelling @ inject site.
Approximately 10 minutes after vaccine administered, child complain of dizziness, itching. Mother reported child pale. Stayed in health department for 40 minutes after leaving . Mother reports that child broke out in rash on chest and right arm. Rash was red, itchy and lasted about 1 hour. Did not to medical doctor. No problem since.
Extremely sore arm from the top of arm right down to the finger tips; Tightening of chest, throat and side of outer neck the glands were tender to touch, Sharp pains going up the side of my head on the right side.
She is still having pain; is experiencing a flare; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received tofacitinib citrate (XELJANZ), oral from 2020 (Batch/Lot number was not reported) to 01Mar2021, at 10 mg, daily, oral from 15Apr2021 (Batch/Lot number was not reported) to an unspecified date, at 10 mg, daily for an unspecified indication; bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation (Age at vaccination: 72 years). The patient's medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient stated that she has been off the medication for 6 weeks since having the Covid vaccine. She is experiencing a flare on Apr2021, and is on pain medication. She had an appointment with her rheumatologist on 09Apr2021. The doctor gave her Prednisone as treatment for her flare reaction and pain. She went back on Xeljanz 15Apr2021. She is still having pain on an unspecified date. The action taken in response to the event for tofacitinib citrate was unknown. Outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
3 hrs post inj severe pain in thigh of inj. 9 hrs post 99.4 temp and 18hrs post inj severe pain to area with pt refusing to walk or stand.
Vaccination was given at 0700, employee began experiencing symptoms approximately at 0830 and were hives, facial swelling and redness and scratchy throat.
patient reported that a few minutes after receiving the second dose in the Moderna series,  she had congestion, a scratchy throat and reported being very thirsty.  Pharmacist administered 10 mL of benadryl (equivalent to a dose of 50 mg) to the patient and sat with her. After the benadryl dose, patient reported feeling better around 10 minutes later, and said that her throat was no longer scratchy and her congestion was better. She was given a bottle of water at the time. Patient  refused immediate medical attention, and was counseled on signs/symptoms of an allergic reaction and what would be signs of a need to go to the ER. Around 45 minutes after her COVID shot, she said that she was feeling much better and wanted to leave.  Pharmacy called a code white and two managers from the back of the store came to check on the patient.
CHIEF COMPLAINT:   pt states he tested positive for COVID 2 days ago. states he is "throwing up and everything". states he cant keep anything down. "i cant give it to my wife and stuff". also feels SOB and has 10/10 abd pain.   HISTORY OF PRESENT ILLNESS:     Patient is a 66-year-old male who presents to the emergency department with shortness of breath, chest pain, abdominal discomfort.  Patient states that he had foot surgery about 2 weeks ago.  He states that he had tested positive for COVID at that time.  He states that he followed up few days ago and tested positive again for COVID.  He states that he had been doing well until about 4 days ago when he started experiencing nausea, vomiting, shortness of breath.  He states that he is feeling very anxious.  Patient has a history of diabetes.  He states that his blood sugar has been controlled in the 100s.  He has not had any diarrhea.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 10-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot # L011079, expiration date 01-OCT-2016, dose, dose# and route not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
1. Arm soreness at injection site. Muscular. 6 hours after injection. Resolved without treatment within 25 hours.  2. Moderate headache 24 hours after injection. Two excedrine migraine pills taken and headache symptoms lessened. Within 2 hours of taking medication.
Patient refers to have presented redness in the administration area, administration area warm to the touch and pain in the arm of the vaccine administration. Refers to after visiting the emergency room have cellulitis.
redness, swelling, pain to lt deltoid tx w/Keflex, Pred, vistaril, DPH;
I had a sore arm and a slight temperature for about two days. I have previously had cellulitis and tendonitis. In 10/2022, I had cellulitis flare up. In 12/2022, I had a tendonitis flair up. I took an antibiotic, topical pain relief and TYLENOL for my symptoms. As of today, I still have tendonitis.
This spontaneous report was received from 58 year old female patient with sulfa drugs allergy, asthma, irregular heart beat and pre-cancer low immune system. On 14-NOV-2011, the patient was vaccinated with a dose of live ZOSTAVAX (lot number, expiry date, dose unspecified), subcutaneously in the arm. No concomitant medications were reported. On 14-NOV-2011, the patient experienced allergic reaction, shortness of breath and her throat was almost swollen shut. On an unknown date in approximately January 2013 (now), she believed that she might be getting shingles again in her left eye. This had a blister in the corner of her eye and her vision was blurry. She did not seek any medial attention till 16-NOV-2011. She was treated with PEPCID, doxycycline by injection, PERCOCET and a warm compress to arm at injection site. She would consult her physician on 10-JAN-2013 (today). The outcomes of all the events were unknown. The relatedness for all the events were unknown for live ZOSTAVAX. Additional information has been requested.
A non-serious spontaneous report of inadvertently administered expired FLUMIST was received from a health professional concerning a 25-month-old male. Neither past medical history nor concomitant medications were reported for this patient. On 29-Nov-2010, product expired. On 09-Dec-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: The reporter is the patient. A 78-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: 301308A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization, reaction(s): "had a rashes on her neck"; Flu (Caller stated she was able to get a flu, pneumonia, shingles shot and never had a reaction); Pneumonia (Caller stated she was able to get a flu, pneumonia, shingles shot and never had a reaction); Shingles (Caller stated she was able to get a flu, pneumonia, shingles shot and never had a reaction); Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization, reaction(s): "had a light pink rash on the neck". The following information was reported: RASH (non-serious), outcome "unknown"; RASH (non-serious), outcome "unknown", described as "the rash came back. It was deeper pink and more widespread". Therapeutic measures were taken as a result of rash, rash. Additional information: It was reported that, the reporter confirmed, her rashes didn't happen right away and didn't notice it the next day. She had no primary care physician and don't take any medication. She tried today and get her booster her pharmacist seemed very reluctant to administer the vaccine and advised to call Pfizer. She never had an allergy to anything and had no primary care physician/allergist. She was able to get a flu, pneumonia, shingles shot and never had a reaction until she took the Covid-vaccine. The reporter was seeking recommendation on what to do going forward. The reporter stated she and her husband were doing the best they could to be healthy. She exercises and walks 2 miles everyday and she was as healthy as she could be. She already got first and second Pfizer COVID-19 vaccine. She didn't actually notice after getting the first shot of the vaccine she had a rashes on her neck she already. She also got the booster shot, the first one and the same thing happened to her. When she got the first shot she did know anything happened. With the second shot, the next day, she had a light pink rash on the neck. Went to patient first, got steroids and it went away in couple days. With the first booster dose, she literally forgot about the previous rash, she went and got the booster dose and the rash came back. It was deeper pink and more widespread. Went to patient first, got steroids again and it went away in couple days. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I have what I call a spastic peeing, I was urinating a lot. I called and made an appointment to see my doctor. He had a urinalysis ran that came back positive for a UTI. I was given a prescription, for Ciprofloxacin and currently taking it now. I have not gotten COVID-19 thanks to being fully vaccinated.
angioedema, generalized hives & fever are reported in pt who recvd flu vax; 4 days p/pt recvd vax pt exp angioedema, generalized hives & fever; pt treated in ER;
16 year patient received Flublok Quadrivalent, no AE; Initial information received on 17-Sep-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16-year-old patient who was vaccinated with a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination on an unknown date.  The patient's medical history, past medical treatment, past vaccination, family history and concomitant medication were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration (latency same day).   At the time of this report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
After 48 hours still running a fever around 99.5; Injection site is red; Tender to touch; Swollen knot about baseball size.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: FC3180) via an unspecified route of administration in the left arm on 06Aug2021 at 19:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, type II diabetes mellitus, hypothyroidism, and obese. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient received unspecified medications in two weeks. The patient had no known allergies. On 08Aug2021, after 48 hours of vaccination, the patient experienced  fever which was still running around 99.5 (unspecified units), her injection site was red, tender to touch and swollen knot about baseball size. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 99.5 (unspecified units), injection site red, tender to touch and swollen knot about baseball size were not recovered at the time of this report.
muscle weakness; All my hair is falling out after the first shot/going to get bald by end of this; I was in bed all the time/didn't even feel like getting up; I feel like I have aged 20-30 years after the Covid and the two vaccines; fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (muscle weakness), ALOPECIA (All my hair is falling out after the first shot/going to get bald by end of this), BEDRIDDEN (I was in bed all the time/didn't even feel like getting up), THERAPEUTIC RESPONSE UNEXPECTED (I feel like I have aged 20-30 years after the Covid and the two vaccines) and PYREXIA (fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced MUSCULAR WEAKNESS (muscle weakness), ALOPECIA (All my hair is falling out after the first shot/going to get bald by end of this), BEDRIDDEN (I was in bed all the time/didn't even feel like getting up), THERAPEUTIC RESPONSE UNEXPECTED (I feel like I have aged 20-30 years after the Covid and the two vaccines) and PYREXIA (fever). At the time of the report, MUSCULAR WEAKNESS (muscle weakness), ALOPECIA (All my hair is falling out after the first shot/going to get bald by end of this), BEDRIDDEN (I was in bed all the time/didn't even feel like getting up), THERAPEUTIC RESPONSE UNEXPECTED (I feel like I have aged 20-30 years after the Covid and the two vaccines) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   This case was linked to MOD-2021-090195 (Patient Link).
JOINTS SWELL; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (JOINTS SWELL) and ARTHRALGIA (Joint pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Rheumatoid arthritis and INFLUENZA VACCINE for Immunization.    No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-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 UPADACITINIB (RINVOQ) (Oral) at an unspecified dose and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. In 2021, the patient experienced JOINT SWELLING (JOINTS SWELL) and ARTHRALGIA (Joint pain). The patient was treated with PREDNISONE at an unspecified dose and frequency. In 2021, JOINT SWELLING (JOINTS SWELL) and ARTHRALGIA (Joint pain) had resolved.            Concomitant medication was not reported.  The patient's joints started acting up after the immunizations (flu and COVID) for a few weeks. Patient had joint pain and her joints swelled so bad that she had to take Prednisone.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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.
On 14FEB2023 I had routine blood work done that showed a low white blood cell count of 3.3. Follow up blood work was done 05MAY2023 and that sdhowed a low white blood cell count of 3.9 and a nutrafill of 1.58.  I did find blood wirk from 2019 that showed a white blood cell count of 4.3.  I do think this is likely coincidental but not necessarily related.  No furher care has been recommended.
Complaining of nausea, sweaty, clammy, finger tingling up to hands & arms. Feeling faint EMT assessed with low BP and assessed in ambulance & discharged home. EKG done Bg = normal
red in the arm of the injection; red went up his shoulder and neck; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (red in the arm of the injection) and ERYTHEMA (red went up his shoulder and neck) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red in the arm of the injection) and ERYTHEMA (red went up his shoulder and neck). At the time of the report, VACCINATION SITE ERYTHEMA (red in the arm of the injection) and ERYTHEMA (red went up his shoulder and neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. No Treatment information  provided
diarrhea; vomiting; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received first dose of BNT162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) administered in left arm on 25Mar2021 at 1800 (at the age of 23-years) for COVID-19 immunisation. No medical history reported. The concomitant medications included zoloft (MANUFACTURER UNKNOWN) and allegra (MANUFACTURER UNKNOWN) for unknown indications. Prior to vaccination patient was not diagnosed with COVID-19. Patient did not receive any other vaccine in four weeks. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 0700, the patient experienced stomach issues including diarrhea and vomiting. Patient did not receive any treatment for events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events stomach issues including diarrhea and vomiting was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Left forearm soft tissue infection at site of previous pneumax IM injection.  Pt tx with doxy with no improvement, admitted to hospital for IV antibiotic therapy with clindamycin (patient with penicillin allergy).
Patient received Pfizer COVID vaccine on 7/9/21 and 7/30/21. On 12/29/21, patient admitted to our facility for acute on chronic diastolic CHF, AKI, and pneumonia due to COVID-19 virus. On 12/31/21, patient was discharged home and during hospitalization, patient remained on room air and did not require dexamethasone therapy.
I have developed a 4 inch x 2 inch itchy red rash at the injection site.