chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a literature source. A 6 month old male presented with jaundice and anemia 2 days after developing cold/flu symptoms, and one month post Prevnar, DTaP, IPV, and hepatitis B vaccines. Autoimmune hemolytic anemia was suspected but the standard DAT and antibody detection tests were negative. The author noted no significant environmental or infectious exposures, bacterial and viral studies were negative, and Hb electrophoresis and glucose-6 phosphate dehydrogenase studies were normal. See lab section for full lab results. He responded to a combination of whole blood exchange, simple transfusion, and immunosuppresive therapy. Six months after presentation his hemoglobin returned to normal and steroid therapy was being slowly tapered. It was the author's conclusion that rare DAT negative AIHA due to low affinity anti-PR presented in this infant following viral infection and vaccinations. This event was considered medically important (OMIC). See copy of attached literature article for additional details.
67 yo M who resides at (Privacy) with PMH as listed.  He is A&Ox to self and , place. He p/w having been found by facility staff at 8 am on the floor with his leg caught on his bed.  He is known to "try to escape" per  his daughter.  THe pt reports low back pain since the fall.   Also, he reports  a 3 day hx of a congested cough, fatigue, and weakness.  He feels short of breath and is tachypneic today---his O2 sat is 95% on RA.  He has a coarse, congested cough in the room.  He reports feeling weak with   decreased intake at the facility the past few days .  There are no reports of LOC or head injury.  He is on chronic eliquis uncertain reasons-- daughter reports cardiologist prescribed.  He denies N/V/D, abd pain., chest pain, fever, or dysuria.  In the ED, he is afebrile w stable HR and BOP.   He is tachypneic to 28 w/  95% oxygen saturation.  Lungs w/  scattered rhonchi.   He leukocytosis to 24 w left shift,  PLTs 135, BUN/creat 40/2.4 (was 17/0.9 in Feb). PCT v10;  he has an AG metabolic acidosis and a lactic acidosis. He is COVID positive .  He is fully COVID vaccinated.   CXR shows no acute process but c/w COPD.  NCCT Head shows no acute IC process; large areas of encephalomalacia left left occipital lobes.   CT cervical and lumbar spine:   Shows acute compression fracture of L2 involving superior endplate in measures approximately 20% with no retropulsion--note similar findings on CT abdomen and pelvis in Dec  2020.  Hospital Medicine has been asked to admit the patient.   PT IS STILL AN INPATIENT
This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown ages and genders. Medical history or concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB (lot # L03087, expiration date: 11-JUN-2018, lot# L035880, expiration date: 11-AUG-2018) (dose and route were not provided). Concomitant medication was not reported. It was also mentioned that no adverse effects were reported, temperature was low 32 degrees F, the time frame was 28 days, there was not previous temperature excursion and there was not product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
first vaccination September 1 2019, has not received second vaccination; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st September 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional details were reported as follows: This case was reported by the patient's wife.  The age at the vaccination was not applicable. The till the time of reporting the patient did not receive second dose, which led to incomplete course of vaccination. Wife asked if Shingrix should be restarted or if boosters were necessary since he was late.  No demographics shared by the reporter and consent was not given for follow up. The reporter did not consent to follow-up
Despite mom giving ibuprofen at the visit and 6 hrs. later, patient still developed at temp of 102.8F and has continued to be febrile with
Large red, warm rash appeared at site injection the day after 2nd dose. Was warm to touch but was not painful however was itchy.
9/26/16 Received PENTACEL, PREVNAR 13 at 7 pm. At 5 am 9/27/16, pale, blue lips, listless, then vomit; settled quickly per mom. She says same reaction after 2 mos vaccines on 6/1/16 (Rota given then too).
past history of diabetes, hypertension, hyperlipidemia and recent diagnosis of COVID-19.  Apparently the patient received his initial dose of COVID vaccine on 03/31/2021 and subsequently developed loss of taste and smell.  He was tested for COVID-19 at local Pharmacy and received notification that his result was positive. He subsequently had improvement in his symptoms and was retested 2 weeks subsequent with negative results.  On for 01/20/2021 he received his 2nd COVID 19 vaccination and subsequently developed recurrence of feeling ill 2 days afterwards. He progressively had feeling of shortness of breath along with nonproductive cough.  The patient then developed complaints of chest pain and rib discomfort.   He presented to the emergency department where he was found to be hypoxic along with abnormal labs including a creatinine of 1.84 BNP of 12,699, elevated transaminase levels, hemoglobin of 8.9.  Chest x-ray showed patchy airspace disease to the right lung consistent with COVID-19 pneumonia.  At time of admission he was given IV Lasix and started on Rocephin and Azithromycin.   The use of steroids as well as any antiviral treatment was withheld because of presumptive symptoms related to bacterial pneumonia (secondary to COVID 19.) He also did not require oxygen supplementation during his stay.
02/10/2006 left shoulder inflamed irritated from area of shot to joint left forearm sensitive to touch x 1 week. L neck repeating sharp pain like a needle stuck in it, 3 days, weak left thumb trouble on and off. 3/4/06 antibiotic prescribed and helped for a while general malaise, minor fever 1degree up, overall exhaustion x 90 days, lymphocyte count increased, muscle pain with walking currently recovering.
Information has been received from a registered nurse concerning a female who was vaccinated with GARDASIL. The patient developed warts on hands after vaccination. The outcome of the patient was unknown. This is one of several reports from the same source. No further information is available.
product stored after expiration; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (product stored after expiration) and EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (product stored after expiration). At the time of the report, PRODUCT STORAGE ERROR (product stored after expiration) and EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications was reported. No temperature excursion and adverse event was reported. Vials was placed in refrigerator on 31 Oct 2021.
Nausea; Dizzy; Flu-like symptoms; Slight fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Slight fever), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced DIZZINESS (Dizzy), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Slight fever) and FATIGUE (Fatigue). On 13-Mar-2021, the patient experienced NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizzy), INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Slight fever), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Patient came to the clinic on 4/9/2021 at 4:30PM and stated that she has been feeling like someone is pinching her all over since she received the first dose of Moderna on 4/1/2021.  She stated that it was not a severe pinching feeling, but irritating because it was consistent.  She had no pruritis, erythema or edema at the injection site.  I told her to take Benedryl as indicated on the bottle and if she did not have relief by Monday, 4/12/2021, to go to an urgent clinic or her physician. She needs a translator and I used a bilingual vaccinator at the clinic to translate.
As or March 2021, I had to begin taking insulin injections. My A1Cs had increased to the point of needing a higher level of care.
Employee had anaphylaxis reaction to the flu vaccine within 5 minutes of receiving dose. Treated with IM  EPI and taken to ER for further evaluation.
1 week after vaccination, pt experienced intense pain and swelling of the left thumb joint which lasted for awhile, and resolved by taking otc NSAID.
Patient received her first dose of Pfizer vaccine, Lot#FK9896. Client alerted RN that her left arm felt heavy after vaccine was administered. RN responded. At 11:58a, client was sitting comfortably on chair in no apparent distress. Client denied significant medical history, medications, and allergies. Client was A&Ox4. Denied difficulty breathing, chest pain, HA, itching or tingling. Vitals at 12:00pm were as follows: BP:140/86, SPO2: 99%, HR:78, RR:14. Client was able to have full range of motion of left arm with no difficulties. Client denied any numbness or tingling. Client denied pain. Client was given a bottle of water. Client was able to consume water with no difficulty. Vitals at 12:20pm where as follows: BP:134/78, HR:80, SPO2 97, RR:14. Client was A&Ox4. Client denied any new symptoms. Client verbalized, ?My arm is feeling better?. At 12:17pm client left vaccination area. Client walked away with a steady gait and unassisted. Client was educated on signs and symptoms of an allergic response and when to seek higher level of care.
nurse accidentally gave Adacel as a 4th dose of Daptacel to a 14 month old female patient, no adverse event; nurse accidentally gave Adacel as a 4th dose of Daptacel to a 14 month old female patient, no adverse event; Initial information received on 11-Jun-2020 regarding an unsolicited valid non-serious case received from a non-health care professional.  This case involves a 14 month old female patient who was vaccinated with the 0.5 ml first dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Prefilled Syringe, batch number: U6668AA and expiration date 30-Apr-2022) via an intramuscular route at an unknown administration site on 09-Jun-2020 for prophylactic vaccination instead of the fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's medical history, past medical treatment, vaccination and family history were not provided.  The patient's concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]), HIB VACCINE CONJ (TET TOX) (ACT-HIB), PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVENAR) and HEPATITIS A VACCINE INACT (HAVRIX) dose received on 09-Jun-2020 for prophylactic vaccination  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  There was no adverse event following medication error.  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.
A spontaneous report was received from a consumer, a female patient (age not provided), who received Moderna's COVID-19 vaccine (mRNA-1273) and reported second dose of vaccine was 20 March, but it was cancelled and would be rescheduled on 31 March 2021 (inappropriate schedule of vaccine administration). The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the events was not provided. On 19 Feb 2021, the patient received her first of the two planned vaccine doses of mRNA-1273 (Lot number: 029L20A) intramuscularly (unknown site) for prophylaxis of COVID-19 infection. The patient was supposed to get the second dose of vaccine, but it was cancelled and rescheduled on 31 Mar 2021. Treatment was not reported. Action taken with mRNA-1273 in response to the events was unknown. The outcome of event was recovered.; Reporter's Comments: This report refers to a case of Inappropriate schedule of vaccine administration, for mRNA-1273, lot #: 029L20A, with no associated AEs.
Systemic: Slowly falling to the floor (felt dizzy) 15 mins after vaccine/ vitals stable called EMS/ patient recently discharge hospitalized for a fall previously
PATIENT RECIEVED HIS FIRST BOOSTER OF PFIZER ONE DAY BEFORE HE WAS ELIGIBLE. (6 MONTHS) PATIENT STATES HE FINE AFTER RECIEVING VACCINE.
About an hour after the vaccine my tongue became swollen, numb and I lost my sense of taste
Moderna COVID-19 Vaccine EUA S/S started with sore arm that progressively got worse.  By 5 pm underarm was tender, pain radiated from shoulder to back shoulder blade area and around the front to breast.  Temp 99.5.  took 800mg Ibuprofen went to bed. 6am 12/31/20 pain still in arm shoulder worse when lift up arm.   pain in back sharp with deep breath. took 1000mg Tylenol.  12pm pain still sharp in back occasional sharp pain in chest on left above breast.
104 degree fever, pale, vomiting repeatedly, crying and difficult to console. Unable to keep anything down orally.
Redness and swelling approximately 5 cm distal of injection site of left arm. Occured approximately 24 hours after Injection. 24 Hours later an additional red spot appeared on inside of Left arm Adjacent to initial swelling spot, Aproximately 3-4 CM.
This case was considered medically important. Information regarding PREVNAR (unspec) was received from a healthcare professional regarding a patient (age and gender unknown) who experienced drug ineffective and bacteremia. The patient received the fourth dose on an unspecified date. Relevant medical history was not provided. Product was administration on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. On an unspecified date after receiving the fourth dose of PREVNAR therapy, the patient presented with bacteremia and (drug ineffective). Treatment consisted of 2 shots of ROCEPHIN and patient was sent home with oral antibiotics. Serotype was not specified at time of the report. Patient was since made a full recovery. No additional information was available at the time of this report.
Pfizer-BioNTech COVID-19 Vaccine EUA: patient hospitalized for COVID-19 infection  Administered oxygen, dexamethasone, and anticoagulation. Intubated then recovered and discharged to home medically stable on oxygen.
Shortness of breath, chills, headache, dizziness occurred with quick onset in the evening on Friday. The symptoms resolved by the morning. Patient felt fatigued for the next 24 hours on Saturday. No symptoms remained by Sunday morning. Patient did not check temperature on Fri. On Saturday morning checked temperature and no fever detected. (Patient Has not had a COVID test)
pt recv vax; red swollen hot area 8x6cm lt arm; red hard area around inject site;
8 days after vaccination experienced swelling, redness, itchiness, heat and hard to the touch of vaccination site.  Also nausea body aches extreme headache.
Light headed; Fever; feeling nauseated; arm very sore/injection site" hurts like a devil; This case was reported by a consumer via call center representative and described the occurrence of light headedness in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2020, the patient received the 2nd dose of Shingrix. In July 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 22nd July 2020, the patient experienced light headedness, fever and nausea. On an unknown date, the outcome of the light headedness, fever and nausea were not recovered/not resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the light headedness, fever, nausea and pain in arm to be related to Shingrix.  Additional case details were reported as follows: The patient reporter that the arm was very sore from the beginning and injection site hurts like a devil. The patient reporter having a fever of 100.4, feeling nauseated and lightheaded.  The patient stated that symptoms have not resolved. The reporter consent to follow up.
This is a new problem. Episode onset: 9 days ago (24h after receiving the 2mo vaccines: Pentacel, Hep B, Rotavirus and Prevnar) The onset was sudden. The problem occurs continuously. The problem has been gradually improving. The rash is present on the abdomen, face, back, left upper leg and left arm. The problem is moderate. The rash is characterized by itchiness and redness. Associated with: 2mo immunizations. The rash first occurred at home. Pertinent negatives include no anorexia, no decrease in physical activity, not sleeping less, not drinking less, no fever, no fussiness, not sleeping more, no diarrhea, no vomiting, no congestion, no rhinorrhea, no sore throat, no decreased responsiveness and no cough. Her past medical history does not include atopy in family. There were no sick contacts.    Mother denies animals at home, new detergent, new formula or food intake. Child did not have any reaction when she received Hep B vaccine as a newborn.
Left hand turned cold for 2 days; Very less thirst; Reduced urine output; Constipation; Sleep disturbance and sleep pattern changed; Vision disturbance; Difficulty focussing; Dreams frequency has increased and are more lucid; Pain at injection site; Fatigue; Light headedness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (Left hand turned cold for 2 days), THIRST DECREASED (Very less thirst), URINE OUTPUT DECREASED (Reduced urine output), CONSTIPATION (Constipation) and DIZZINESS (Light headedness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3002179) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced DIZZINESS (Light headedness). On an unknown date, the patient experienced PERIPHERAL COLDNESS (Left hand turned cold for 2 days), THIRST DECREASED (Very less thirst), URINE OUTPUT DECREASED (Reduced urine output), CONSTIPATION (Constipation), SLEEP DISORDER (Sleep disturbance and sleep pattern changed), VISUAL IMPAIRMENT (Vision disturbance), VISION BLURRED (Difficulty focussing), ABNORMAL DREAMS (Dreams frequency has increased and are more lucid), VACCINATION SITE PAIN (Pain at injection site) and FATIGUE (Fatigue). On 21-May-2021, SLEEP DISORDER (Sleep disturbance and sleep pattern changed) had resolved. At the time of the report, PERIPHERAL COLDNESS (Left hand turned cold for 2 days), THIRST DECREASED (Very less thirst), URINE OUTPUT DECREASED (Reduced urine output), VISUAL IMPAIRMENT (Vision disturbance), VISION BLURRED (Difficulty focussing), ABNORMAL DREAMS (Dreams frequency has increased and are more lucid), VACCINATION SITE PAIN (Pain at injection site) and FATIGUE (Fatigue) outcome was unknown and CONSTIPATION (Constipation) and DIZZINESS (Light headedness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant product use was reported  No treatment information was provided
within 8 hours major tenderness in the arm along with hand pain/aches, thumb was kind of numb. Hot flashes through the night and then chills for about 12 hours of the day after. Fatigue, some nausea and lack of appetite.  General body aching similar to when I had Covid 6 months ago, worse in chest, neck and upper body. No fever noted. Ibuprofen taken to relieve pain and aches.
Since August 2021, all day and all night I smell cigarette smoke. I literally chokes me and burns my eyes. It is constant. There are very few times I don't smell it. I went to my primary doctor and chiropractor and neither of them knew what to do. They believe it could be because I had covid back in 2019 or related to the vaccine. I have received no treatment for it. They said there's nothing they can do.  I have tried a number of home remedies and nothing works.
developed lump on the same side where the vaccine was administered; This is a spontaneous report received from a contactable consumer (patient's mother) via medical information team. A 26-year-old male patient (reporter's son) received first and second doses BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown) both via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient got his first dose and developed a lump after the administration initially which did not disappear (just got smaller) not until his 2nd dose where he developed the same lump on the same side where the vaccine was administered on an unspecified date. Reporter would like to know how long do they need to wait until they seek further medical treatment or medical advice from their doctor. Also, if the lump will resolve on its own. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.