chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 04-May-2022 post 30 days; Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 04-May-2022 post 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 04-May-2022 post 30 days) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 04-May-2022 post 30 days) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 003F21A, 038B21A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 04-May-2022 post 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 04-May-2022 post 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 04-May-2022 post 30 days) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 11-Jan-2022 and administered to the patient on 04-May-2022 post 30 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported by pharmacist, the vaccine coordinator in their health care facility, that they inadvertently administered an expired dose of the Moderna Covid-19. Post further investigation of the issue, pharmacist identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number 084J21A was received and placed in the fridge initially on 11-Jan-2022, which means that all doses administered more than 30 days after 11-Jan-2022 were not in accordance with the EUA. The vial did not undergo any temperature excursions. The patient did not report any adverse reaction to the health care professional's knowledge.  No treatment medication was reported.
Extreme pain (close in intensity to child birth) in the lymph node armpit area on the side side of the injection site! I was crying while changing my clothes the next morning. Very swollen and sore! Pain got better over the next few days with ibuprofen and swelling went down. On the 4th day after the injection bruising (like someone threw a basket ball at me) appeared in the lymph area.  Low grade fever, mild headache, mild nausea, extreme fatigue accompanied the lymph pain only during the first 24 hrs after the injection.
I developed a runny nose, headache, and low grade fever with a cough.  I tested for COVID-19 on the 25th and was negative with a home test.  I finally tested positive two months later when I went to the Emergency room.  They prescribed me steroids' and an Asthma Inhaler names Albuterol.
Starting about 20 minutes after shot (after I left vaccination site), I experienced some throat and lung tightening,  hoarseness, racing heart, stomach cramping (symptoms similar to what I experience when I accidentally ingest a small amount of peanuts, except it didn't affect my mouth.)   Symptoms did not worsen and I took 2 OTC Benadryl at about 40 minutes after shot upon arriving home (and alerted another adult at home that I was having a mild reaction).  Allergic symptoms subsided about 60-75 minutes after shot.  I discussed allergic reaction with my PCP at a previously scheduled appointment on 4/6/21, but did not seek medical attention.
my penis does not work; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PENIS DISORDER (non-serious), outcome "unknown", described as "my penis does not work".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tested positive for COVID-19/Nasal Swab: Positive; tested positive for COVID-19/Nasal Swab: Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 34-year-old female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Feb2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient was 37 weeks pregnant at the event onset. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "recovered" (2023) and all described as "tested positive for COVID-19/Nasal Swab: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2022) Positive; (Feb2023) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Reported as, Patient received the Pfizer booster at 37 weeks of pregnancy and tested positive for COVID-19 while in the hospital to give birth 3 weeks later.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient complaint of Body aches, nausea, headache, and sore arm. Patient was given Tylenol 650 mg TID PRN for pain X 7 days.
Right eye started to have discomfort within 3-4 hours after the vaccine.  Then, 11-13 hours later, right side of face, especially around the eye area started to swell up like crying eyes after a few days of crying. Then 16-17 hours later, the right eye was so swollen that the eye is half of its size because of the swelling.  The right eye, cheek, right side of face was swollen for one week before it got back to normal.  The eyelid on the right side has pain when pressed on it.
Severe pain in left arm causing him to lose sleep for 1 night. No edema erythema, fever. Pain resolved 05/16/04.
Patient was inoculated.  He has a periorbital cellulitis requiring admission.  He has no corneal or conjunctival involvement.  He is admitted today for observation/IV antibiotics and VIG when it arrives. His roommate received the vaccine approximately 3-4 weeks ago, details to follow.  Nurse follow up on 08/23/04 states: "Discharge summary confirms diagnosis of secondary inoculation of vaccinia causing orbital preseptal cellulitis. Additional symptoms noted were periorbital edema, headache, and pustule & erythema."
redness; sore arm; injection site was hot" and "swollen".; injection site was hot" and "swollen".; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness), PAIN IN EXTREMITY (sore arm), VACCINATION SITE WARMTH (injection site was hot" and "swollen".) and VACCINATION SITE SWELLING (injection site was hot" and "swollen".) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Seasonal allergy.   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (redness), PAIN IN EXTREMITY (sore arm), VACCINATION SITE WARMTH (injection site was hot" and "swollen".) and VACCINATION SITE SWELLING (injection site was hot" and "swollen".). At the time of the report, ERYTHEMA (redness), PAIN IN EXTREMITY (sore arm), VACCINATION SITE WARMTH (injection site was hot" and "swollen".) and VACCINATION SITE SWELLING (injection site was hot" and "swollen".) outcome was unknown. Not Provided          Concomitant medication included cholesterol medication, seasonal allergies medication. Treatment information was not reported.   This case was linked to MOD-2021-022565 (Patient Link).
ACHING BODY (INCLUDING THE CHEST AND AROUND THE AREA  OF THE VACCINATION); NUMBNESS IN LEFT FINGER; CHILLS; HEADACHES; NAUSEA; This spontaneous report received from a patient concerned a 40 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 042A2A and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021; 13:16 on left deltoid for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced aching body (including the chest and around the area of the vaccination). On 06-APR-2021, the patient experienced numbness in left finger. On 06-APR-2021, the patient experienced chills. On 06-APR-2021, the patient experienced headache. On 06-APR-2021, the patient experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, chills, and aching body (including the chest and around the area of the vaccination), and had not recovered from headache, and numbness in left finger. This report was non-serious.
BLOOD CLOTS; This spontaneous report received from a consumer concerned multiple patients of unspecified sex, race and ethnicity. No past medical histories or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy dates were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, multiple patient developed blood clots.  As per the reporter "consumer states that she knows that people have had blood clots after the Janssen COVID-19 vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcomes for the multiple patients with blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220115938-Covid-19 vaccine ad26.cov2.s- Blood Clot. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Day 1: Strange behavior.  Drooling.  Inability to talk.  Leading up to prolonged seizure at approximately 10:45 AM. Day 3: Febrile seizure at 5:42 AM.  ER.  Prescribed medication to control fever as well as anti-seizure medication (Keppra). Day 4: Test positive for H1N1. Day 6: Facial spasms. Day 7: To be continued... 11/20/09 Medical records received for dates 11/14/09 to 11/16/09. DX: viral syndrome, febrile seizure. Presenting SX: Pt at OV for f/u seizure. Pt. parent states fever x1 wk ago then a 15 min tonic clonic seizure, taken to hosp. by EMS. Following day another seizure w/ upper body stiffness, taken to ER placed on meds. (+)family h/o febrile seizures. Assessment (+)runny nose, congestion, cough, irritable. EMS records 11/15/09: EMS called found pt. in full body seizure, hot to touch, pt. became alert en route to ER.  ER DX: complex febrile seizure, acute febrile illness.  11/15/09 Neuro consult. DX: seizures.
Menstrual cramps but no period; Exhaustion; Nausea; Headache; Low fever; Cough; This is a spontaneous report from a contactable consumer (Patient). A 43-year-old non pregnant female patient received second dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: ER8731 and expiration dates were not reported), via unspecified route of administration in the left arm on 18Apr2021 as dose 2, single for COVID-19 immunization. The patient's medical history included Rheumatoid arthritis, bipolar type 2, asthma from an unknown date and unknown if ongoing. On an unknown date the patient experienced allergy to Penicillin, erythromycin, Zithromax, vancomycin, duracef, darveset, amoxicillin from an unknown date. Concomitant medications included ZYPREXA (olanzapine), LAMICTAL (lamotrigine), OTREXUP (methotrexate), CELEBREX (celecoxib), B12-VITAMIIN (cyanocobalamin), VitaminD3 (cholecalciferol) all products from an unknown date for an unknown indication. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: ER877 and expiration dates were not reported), via unspecified route of administration in the left arm on 28Mar2021 as dose 1, single for COVID-19 immunization. On 22Apr2021 after 04 days the patient experienced Menstrual cramps but no period, exhaustion, nausea, headache, low fever and cough. The patient did not received treatment for the adverse event. No other vaccine in four weeks and no vaccine was administered prior to the COVID vaccination. The outcome of the all events was recovered.  No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a 17 year old female patient with penicillin allergy and without illness at time of vaccination, who on 12-NOV-2008 at 11:30 was vaccinated with the third dose of 0.5ml GARDASIL (lot # 661766/0652X)  IM in the right arm and concomitantly at the same time with FLUVIRIN (lot # 89981) IM in the right arm.  On 12-NOV-2008 at 11:55, the patient experienced syncope.  The patient was sitting in exam room after injection for 15 minutes, with no problems, after getting up and walked in the hallway, she fell to the ground.  Right after hitting the ground she opened her eyes.  On the same date, the patient recovered.  The patient sought unspecified medical attention.  Additional information has been requested.
Rash - erythematous & clear vesicles on face, abdomen, arms & legs. Pt stated fever, chills, temp during office visit normal but had taken fever reducer.
Extreme dizziness, headache,  skin dryness,, blurry vision, left knee pain,
Myo-pericarditis. Hospitalized for 3 days from severe chest pain. Hospital tests came back with troponin levels at heart attack severity.
Sore arm; This is a spontaneous report from a contactable consumer (patient).   A 75-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported), (at the age of 75-year-old) as SINGLE DOSE for covid-19 immunisation.  Medical history included High Blood Pressure, osteoporosis, Overactive bladder.  The patient received second shot on the 06Feb (not clarified). After the first shot, the patient had no symptoms except for sore arm. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Approximately 30 minutes after receiving immunizations, pt returned to clinic with swollen eyes, referred to ER.
Extreme dizziness with nausea and vomiting that starting on 12-26-2020 after receiving the vaccine on 12-24-2020
On May 20 2021, I finally went to the doctor and I felt like I was having a hard time breathing and it would come and go. It wasn't constant. I could feel everything draining allergy wise. The breathing I've never felt before so I went to the urgent care and he said it was a upper respiratory infection. Didn't test me for COVID but put me on antibiotic to help. I did get better. But after that, I can kind of feel that I wasn't 100% even though my oxygen levels were normal. At the end of august, I got really sick. I missed a whole 7 days of work. When I got sick again, they did test me for COVID and it was negative. I was wheezing, and having a real rough time. They did a chest x-ray and said it was pneumonia. Even after that, 3 weeks after with an antibiotic and inhaler, I was still feeling bad. I went back to a different doctor and she tested me for COVID and it was still negative. It was a raw type thing in my chest. Everything was just draining from my ears and sinus cavities. The ENT stuck a tube down and it was uncomfortable and I gave up with that test. Even now I still have on and off symptoms where I still have fluid draining and I feel like it's raw and this weird feeling in my breath. I'm not saying I'm not breathing, but the feeling is still present. I've tried taking OTC things such as Mucinex, allergy meds, and other medications to get whatever is in me out of me but it doesn't feel like it's gotten better. Wasn't like this before. During that time- I was very nervous, had some anxiety. After my 2nd vaccine- as soon as they injected the vaccine, felt  this feeling across my chest- wave that passed through. It could have been anxiety but within the next 24 hours, the feeling went away.. Was having a hard time with the breathing feeling because that came on during this time, but did not require medical attention. This is when the breathing feeling began, went away, then came back in May. Since May 2021,  it's been on and off to present day (February 2022).
14AUG98 pt presented w/ vomiting, itching, slight dizziness, BP 124/67 P 84, tx DPH
patient fell asleep and did not wake up for more than 24 hours to go to the bathroom, then fell asleep again for another undetermined length of time.  Patient came in today to report adverse reaction otherwise seems to be okay today
24 hrs p/#3 DTP site became swollen, area red & hard, fever 103 responded well to APAP;
Extremely tender, sore and swollen arm, very sore throat, 101+ temperature and sleepiness & fatigue
Patient received a Shingrix shot and Fluzone HD shot this past Saturday. She insisted she have them in the same arm. She woke up Sunday morning feeling very fatigued and stayed in bed most of the day. She felt better on Monday (same day she reported the adverse event). She stated her arm was a little swollen and hurt. I explained to her this was most like an injection site reaction and to apply ice to the painful arm for 20 minutes and then remove for 20 minutes and to also take Motrin or Tylenol for the pain. Instructed her to call me back if she experienced any new or worsening symptoms and I told her I would call her tomorrow to check on her.
Less than 48 hours after vaccine, went to ER with confusion, (R) arm pain & unable to move hand. Patient was transferred from one hospital ER, to another hospital ER developed lower extremity weakness. MD was felt to be suggestive of demyelinating disease. Received LEVAQUIN and acyclovir for (R) arm erythema. Started on IV SOLUMEDROL on 7/29. Pt discharged & f/u with PCP, neurologist, occupational/physical therapy.
Patient was dizzy, lightheaded, and had tachycardia. They had tingling in hands and feet. No anaphylaxis noted. They were transported by EMS.
Patient received vaccinations, IPV # 4, DTaP #5, MMR #2 on 5/4/04, in the left arm. The patient developed itchiness, redness and swelling on 5/05/04. Seen 05/06/2004, no fever, no pain at sit of vaccination.
Chills, musculoskeletal pain, headache, sinus pain, nausea, tooth sensitivity
ZOSTAVAX administered L arm subcutaneously at 1600. Within 20 min. pt c/o tingling tongue and warm lips. Progressed to "burning" tongue with "whistling" sounding wheeze upon exhalation. Methylprednisone 40 mg IM admin. per MD order. Pt left office 20" later - Sx's improved.
Information has been received from a medical assistant referring to multiple unknown patients. The patients' concurrent condition, medical history and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored (6.6 degrees Fahrenheit for 30 minutes) doses of PROQUAD (dose and route were unknown, lot # and expiration date were M009746, 23-AUG-2017; M015695, 26-SEP-2017; M011660, 08-SEP-2017; M006101, 01-AUG-2017). Only one of the lot number (M006101) had previous excursion under 11.3 degrees Fahrenheit for 1 hour and 20 minutes. Data logger was involved. No adverse event was reported. This is one of two reports received from the same reporter. Additional information has been requested.
After chronic Otitus Media following his 11/1/96 Polio/DTPHiB vaccine, pt regressed into Autistic Spectrum Disorder during the months following his 6/25/97 vaccinations. (MMR, Varivax)
After 2 weeks of first dose of COVID vaccine, on Friday Feb 26th around 5 pm, he had allergic reaction on his left arm where the shot was given.  A large red flame area around the arm of the shot area and itchy too.  His lower leg have the same large red area of itchiness.  He took benedryl and applied hydrocortisone to ease the itch.
pt recv vax OCT95 & in JUN96 respectively was found to be a nonresponder;
Rebound case of COVID; Rebound case of COVID; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 14Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BENAZEPRIL; ASA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02May2022, outcome "recovering" and all described as "Rebound case of COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. Anti-viral details: Product-COVID 19 Treatment Brand-Paxlovid, Treatment start date-12Apr2022,Treatment stop date-16Apr2022, Indication-Treatment of COVID-19  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.