chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am still having like arm pain in my left arm; I get like tingling and now it is little weak; I get like tingling and now it is little weak; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL0142, Expiration date: 21Mar2021), via an unspecified route of administration on 07Jan2021 (at the age of 52-years) as dose 2, single for covid-19 immunisation. The patient medical history included high blood pressure. The patient concomitant medications included Vitamins from an unknown date and unknown if ongoing. The patient previously first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EK5730, Expiration date: 20Mar2021), via an unspecified route of administration on 17Dec2020 (at the age of 52-years) as dose 1, single for covid-19 immunisation. On unspecified date, the patient experienced still having like arm pain in my left arm and get like tingling and now it was little weak. The patient received treatment for events with Advil, Tylenol. Patient stated that "After the second vaccine I noticed, but then like 2 days after the second one and then it just has not stopped, like sometimes it start tingling so bad that I have to open up my hand few times and almost like it went to the sleep, it just, I don't know it just hurts, yes few days after the vaccine. Recently yes, I have, yeah, they actually just checked it just to make sure my electrolyte is good, which was fine. It is just under control, I am taking medication for it." The outcome of the events was not recovered.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Chills, body aches, headache, fever, blood in urine, frequent bowel movements
Injection site (left deltoid) became sore the day of the injection and then painful. Pain worsened, and pain extended to entire left arm. Also had some numbness to hand & fingers within days of the injection. Pain/numbness persisted >2 months, but is somewhat better now. Physician anticipated recovery will take 6 months and believed it to be nerve-related damage.
Patient called on 11/1/2022 to report left shoulder pain onset 10/12/2022.  Pt came to facility on 11/3/2022 and reported L shoulder pain onset as above. Pain has not changed in intensity since onset. He has pain in L deltoid only with lateral abduction and shoulder extension. Shoulder flexion, adduction, and placing forearm on low back do not elicit pain. There is no tenderness to palpation or touch anywhere on shoulder or arm. All pain is reported as "internal". He denies paraesthesias or weakness.  Patient reports that he has contacted an attorney familiar with SIRVA and has scheduled an appointment later in the month - he is unsure of the date, possibly 11/22/2022
Infant received 3 vaccines about 11:30. Was given acetaminophen and woke up screaming at 14:30; shuddering with jerking of head and shoulder girdle (mild). Parents relate he did this up to 2 weeks of age. By the time he was seen by me, his condition had lessened, considerably at 17:30. Referred to pediatric neurology.
Diarrhea; Tenderness if she pokes the injection site; Arm swollen; Inflammation hardness; Inflammation hardness; Allergic reaction; Felt a little tired and the arm was hurting a bit; Little tired; Forehead, nose and cheeks got really red and burning, Burning sensation in face, Burning sensation; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ALLERGY TO VACCINE (Allergic reaction), PAIN IN EXTREMITY (Felt a little tired and the arm was hurting a bit), FATIGUE (Little tired), ERYTHEMA (Forehead, nose and cheeks got really red and burning, Burning sensation in face, Burning sensation) and DIARRHOEA (Diarrhea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to animal (allergic to duck), Allergy to animals (allergic to turkey), Drug allergy (allergic to Cataprist,), Drug allergy (allergic to Januvia), Drug allergy (allergic to Keflex.), Diabetes mellitus, Hypertension and Hypercholesterolaemia.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced ALLERGY TO VACCINE (Allergic reaction), PAIN IN EXTREMITY (Felt a little tired and the arm was hurting a bit), FATIGUE (Little tired) and ERYTHEMA (Forehead, nose and cheeks got really red and burning, Burning sensation in face, Burning sensation). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Tenderness if she pokes the injection site), PERIPHERAL SWELLING (Arm swollen), INFLAMMATION (Inflammation hardness) and INDURATION (Inflammation hardness). At the time of the report, ALLERGY TO VACCINE (Allergic reaction), FATIGUE (Little tired), ERYTHEMA (Forehead, nose and cheeks got really red and burning, Burning sensation in face, Burning sensation), DIARRHOEA (Diarrhea), VACCINATION SITE PAIN (Tenderness if she pokes the injection site), PERIPHERAL SWELLING (Arm swollen), INFLAMMATION (Inflammation hardness) and INDURATION (Inflammation hardness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were not provided.
No additional AE details.; administered GARDASIL 9 too soon inadvertently; This spontaneous report was received from an other health professional, referring to a 22-year-old male patient. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On 04-FEB-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (lot # T036442, expiration date: 09-APR-2023, dose, strength and route were not provided) for prophylaxis. On 08-APR-2022, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (lot # T036442, expiration date: 09-APR-2023, dose, strength and route were not provided) for prophylaxis. On 13-MAY-2022, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) injection (lot # T036442, expiration date: 09-APR-2023, dose, strength and route were not provided) for prophylaxis (inappropriate schedule of product administration). No additional adverse event details.
H1N1 vaccine given to child, after Mo request. Mo denies prev. H1N1 vaccination when asked by CNA & RN ok 2 different times. After review of vaccine record, documentation of swine flu noted 11/17/09 17 days between vaccines. No reaction noted.
Breathing difficulty, Nausea, Diarrhea, Fever, Chills, Body Aches.  Patient stated she had to go the  emergency room on 6/4/2021
patient was administered the vaccine on 7/22/2022,the same form listed an exp date for the product of 7/11/2022 with no reported adverse event; Initial information received on 03-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who was administered the vaccine on 7/22/2022,the same form listed an exp date for the product of 7/11/2022 with no reported adverse event involving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received a 0.5ml 1X(once) dose of suspect HIB (PRP/T) VACCINE (strength, formulation was unknown, lot UJ525AAB and expiry date: 11-Jul-2022) via unknown route in unknown administration site for Immunization.  It was reported that the patient developed a non-serious event was administered the vaccine, the same form listed an exp date for the product of 11-Jul-2022 with no reported adverse event (expired product administered) (onset date: 22-Jul-2022, latency: same day) following the administration of HIB (PRP/T) VACCINE. They received the vaccination report for the patient and the expiry date listed falls about 11 days before the vaccination was administered. They were asking if we can confirm the expiration date based on the lot number of the product, and how to proceed from here. Reporter does not have the actual product so they cannot see the date on the package, it was located at another pharmacy that administered the vaccine.  Action taken with HAEMOPHILUS TYPE B (HIB) VACCINE (ACT-HIB) was not applicable.  Outcome: Unknown  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 the guidelines. 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.
Received vaccine Mon 6/3 states arm started swelling but no pain until Tuesday morning. Swelling is the same but it has become more painful. Whole arm hurts, burns down to wrist when she moves it. Dr looked at her arm and said it did not look like abscess - no drainage. Warm and tender to touch to take 800mg Ibuprofen every 6-8 hrs for 5 days and put cold compresses on and off. In health dept 6/5/13 3pm.
Severe Hemolysis; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOLYSIS (Severe Hemolysis) in a 63-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Paroxysmal nocturnal hemoglobinuria.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMOLYSIS (Severe Hemolysis) (seriousness criterion medically significant). At the time of the report, HAEMOLYSIS (Severe Hemolysis) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       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  Concomitant medications were not reported.  Treatment medications were not reported.  CC: This spontaneous case concerns a 63-year-old, male patient with an underlying paroxysmal nocturnal hemoglobinuria, who experienced and unexpected, medically significant event of Severe hemolysis in association with a dose of mRNA-1273 vaccine. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying paroxysmal nocturnal hemoglobinuria remains a confounder in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns a 63-year-old, male patient with an underlying paroxysmal nocturnal hemoglobinuria, who experienced and unexpected, medically significant event of Severe hemolysis in association with a dose of mRNA-1273 vaccine. Further details on the medical history, clinical course, diagnostics, and treatments were not reported. Patient's underlying paroxysmal nocturnal hemoglobinuria remains a confounder in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event's seriousness assessed based on medical judgement.
The day after my vaccination my shoulder was sore at the injection site. As the day went on my inner right armpit really became swollen and uncomfortable.
"Pt received first Pfizer vaccine at 0920.  At 0922 he became lightheaded and fainted. He fell out of his chair onto the floor. RRT was called at 0922.He regained consciousness and was alert to person and place.   VS 02- 98% BP 86/36   House supervisor and Pharmacist arrived at 0923. Pt was conscious and talking. He did not report any injury to his head or neck. He states he hit his shoulder and may have bitten his tongue. Observed a small contusion on his tongue. No bleeding at this time.  He denies being diabetic. 0927-Vital signs  O2 97% BP- 104/64 Pt sat up and was given juice. He states he feels better and has fainted before with blood draws.  0931 Vital Signs-BP 97/82 02 96% 0945 Vital signs BP 96/77 02 98% Pt standing up and able to walk to hallway.    Given water and a granola bar.  0949- Pt called his wife.  1002 BP 108/73. He states he is feeling better, and standing.  1005-BP 123/80 1010 Pt escorted to elevator and to Cafeteria. Reports no pain.  He states he feels well and will eat something more and go home. "
The patient received the incorrect manufacturer of the covid vaccine for her second dose. She got a Pfizer vaccine on her first dose and for her second dose, she was incorrectly given Moderna
Initial report received from a healthcare professional on 06 November 2012. A male patient (age and date of birth not reported), who had allergies possibly to eggs and fish, no history of medical conditions and concomitant medications were not reported, had received a dose of FLUZONE (batch number was unknown, route and site of administration were not reported) on an unspecified date about 1 week ago. The reporter stated that, on an unspecified date about 1 week ago, within 5 minutes of vaccination the patient experienced swollen, bright red ears and cheeks. The patient received corrective treatment with BENADRYL. Laboratory data was not reported. On an unspecified date, the patient had recovered. Follow-up information received from a healthcare professional on 01 July 2013: The patient address details were updated. List of documents held by sender was none.
experienced a high pitch tone in the head described as ringing but it is from the head persistent until 01Jun2021; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (experienced a high pitch tone in the head described as ringing but it is from the head persistent until 01Jun2021) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 028A21H) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (experienced a high pitch tone in the head described as ringing but it is from the head persistent until 01Jun2021). At the time of the report, TINNITUS (experienced a high pitch tone in the head described as ringing but it is from the head persistent until 01Jun2021) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: the Follow up received on 14-JUN-2021, patient details updated, event onset date updated , causality updated.
herpetic zoster keratitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77 years old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 22-AUG-2012, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced Herpetic Zoster Keratitis. On an unspecified date, the patient was treated by a healthcare provider for herpetic zoster keratitis. The outcome of the event herpetic zoster keratitis was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the event herpetic zoster keratitis was determined to be medically significant.  Additional information has been requested.
cough, sore throat Narrative: Employee received first dose of Moderna vaccine on 08/25/21 at 430pm. No other symptoms reported, no medications were reportedly used. Reports seeing a doctor for symptoms, however no other information was provided. Employee has since recovered.
Redness, swelling, itching left thigh for 1 day- red/raised indurated area with color non tender- pt. seen in clinic 5/28/04.
Patient had immediate swelling of immunization site on L leg after administration of MMRV Vaccine. Swelling remained localized and did not spread. Patient's provider was notified and was given a cold pack to reduce swelling. Patient was monitored for 20 minutes and swelling on L Leg decreased over time. Patient was seen with her provider and was released to go home with her mother and sister.
pt recv vax 27MAY97 & 3JUN97 pt broke out & devel a fever of 103;4JUL97 pt presented to MD office;
Patient has a history of simple Prostatectomy and Kidney Stone. He had the first Moderna Covid 19 vaccine on 2/3/2021 and the second dose 3/8/2021. 5 days ago He started with severe dizziness and next day he was admitted to hospital for severe Urosepsis.
Swollen lymph nodes and arm pit for 5 days day after booster.  Pain and swelling in same area for 1 day about 3 weeks after. Large bald spot on half of left side of head.
Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient received two vaccines in same day (Fluad and Pfizer Covid Bivalent) in opposite arms. Woke up next day with rash all over body. Patient was instructed to call physician for further evaluation. Patient did not report any other symptoms other than rash
12 years old - patient received her first covid19 Pfizer vaccine at Pharmacy on Tuesday, 8/3/2021 at 12:30pmish symptoms -  8/3/2021 - sore arm - Tylenol 9pm 8/4/2021 - sore arm and - 200 mg pill Advil advised to give by pharmacist 10am 8/4/2021 - sore arm, heart hurts/discomfort striking/zap feelings in her heart - 200 mg Advil 5:30pm patient told me this morning 8/5/2021 she felt her heart beating in her neck yesterday morning 8/4/2021.  8/5/2021 - contacted Dr.'s office and explained patient's symptoms after receiving the Pfizer vaccine and (nurse practitioner) said the doctors said take patient into the ER to do an EKG test. ER took an X-ray of patient's chest and did an EKG.  Everything came back normal.
Varicella-like rash began 2-3 days after varicella vaccine administered.
Patient had a febrile seizure approximately 12 hours after the vaccine ( second dose) He was post ictal and was seen in a local ER a, diagnosed with a probable febrile seizure, and was discharged to home.  On follow up in my office several days later, his exam was non-focal ( normal) . I reviewed the history with the parents and medical records and concur that patient had a febrile seizure following the vaccine administration.
became real ill after the second shot; had a fever of 103; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (became real ill after the second shot) and PYREXIA (had a fever of 103) in a 57-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (became real ill after the second shot) and PYREXIA (had a fever of 103). At the time of the report, ILLNESS (became real ill after the second shot) and PYREXIA (had a fever of 103) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: had a fever of 103.         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.   This case was linked to MOD-2022-620739 (Patient Link).
3 patients received vaccine from vial opened more than 12 hours ago; Administered vaccine from a Moderna COVID-19 vial that had been left out at room temperature and was punctured on 14-Dec-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients received vaccine from vial opened more than 12 hours ago) and PRODUCT STORAGE ERROR (Administered vaccine from a Moderna COVID-19 vial that had been left out at room temperature and was punctured on 14-Dec-2021) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Dec-2021 at 4:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients received vaccine from vial opened more than 12 hours ago) and PRODUCT STORAGE ERROR (Administered vaccine from a Moderna COVID-19 vial that had been left out at room temperature and was punctured on 14-Dec-2021). On 15-Dec-2021, EXPIRED PRODUCT ADMINISTERED (3 patients received vaccine from vial opened more than 12 hours ago) and PRODUCT STORAGE ERROR (Administered vaccine from a Moderna COVID-19 vial that had been left out at room temperature and was punctured on 14-Dec-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   It was reported that the vial was punctured on 14-Dec-2021.The vial did not undergone any temperature excursions. The vial was stored at room temperature post puncture.   This case was linked to MOD-2022-459158, MOD-2022-459148 (Patient Link).