chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program.   A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included COVID (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s) food was more sour; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s) The second, too salty. The following information was reported IMMUNISATION (non-serious), outcome unknown; DYSGEUSIA (non-serious), outcome unknown.  The patient had some strange side-effects with all 3 shots of the Pfizer vaccine. When patient had COVID, lost sense of taste for 5 months before it came back. Each time, for between 1-3 days after getting the shot, food tasted strange. With the first shot, food was more sour, the second, too salty, and with the last one, more bitter.  The lot number for bnt162b2 was not provided and will be requested during follow up.
SORE ARM; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 03-SEP-2021, the patients experienced sore arm. The action taken with covid-19 vaccine was not applicable. The outcome of sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210908676 and 20210908685.
APPROXIMATELY 1 DAY AFTER FLU VACCINE WAS ADMINISTERED, PATIENT BEGAN TO NOTICE INTERMITTENT NUMBNESS IN HER LEFT ARM, AND CONSISTANT NUMBNESS IN HER LEFT HAND. PATIENT COMPLAINS OF PAIN ALSO IN THE ARM, INCLUDING NOT BEING ABLE TO CARRY HER PURSE, OR LAY ON HER LEFT SIDE DURING SLEEP. NO TREATMENT THUS FAR, PRESENTED TO PHARMACY TO REPORT REACTION 4 DAYS AFTER RECEIVING VACCINE WITH NO RELIEF
muscle ache; severe joint pain; severe fatigue; joint ache; rash; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (muscle ache), ARTHRALGIA (joint ache), RASH (rash) and ARTHRALGIA (severe joint pain) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Demoral allergy was reported). Concomitant products included TESTOSTERONE (FORTESTA) and COLESEVELAM HCL for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced FATIGUE (fatigue). On 02-Feb-2021, the patient experienced ARTHRALGIA (joint ache) and RASH (rash). On 09-Feb-2021, the patient experienced MYALGIA (muscle ache), ARTHRALGIA (severe joint pain) and FATIGUE (severe fatigue). At the time of the report, FATIGUE (fatigue), MYALGIA (muscle ache) and RASH (rash) had not resolved and ARTHRALGIA (joint ache), ARTHRALGIA (severe joint pain) and FATIGUE (severe fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Blood glucose: (High) High and high (High) high. On 09-Feb-2021, Glycosylated haemoglobin increased (6.3-7.8): increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       traeatment medication Triamcinlone Cream for Rash.,rednisone were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-026992 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: added concomitant medication, patient demographic. event, historical condition ,lab data, treatement medication; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-026992:cross link
Guillian-Barre Syndrome/Acute inflammatory demyelinating polyradiculoneuropathy - ascending paralysis and paresthesias along with autonomic symptoms. Refractory to IVIG. Patient was sent home after course but then continued to worsen and couldn't ambulate . She was readmitted and started on plasmapheresis and pulsed steroids. Respiratory function has been relatively spared, but she has not clearly yet obtained her nadir.
Initial report received from a healthcare professional on 07 November 2013. A patient received PENTACEL and some squirted during administration of first dose. (No information was provided regarding the patient). No adverse event was reported.
felt like trash; I feel hot; Aches and pain; upset stomach; it has not been fun; been in bed; feel trash; headache; "beat red" face; swollen lips; Swollen neck and chest; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA ("beat red" face), LIP SWELLING (swollen lips), SWELLING (Swollen neck and chest), FEELING HOT (I feel hot) and PAIN (Aches and pain) in a 66-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.     Concomitant products included ALPRAZOLAM (XANAX), ROSUVASTATIN CALCIUM (CRESTOR), FOLIC ACID and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced ERYTHEMA ("beat red" face), LIP SWELLING (swollen lips), SWELLING (Swollen neck and chest), FEELING ABNORMAL (feel trash) and HEADACHE (headache). On 25-Mar-2021, the patient experienced FEELING HOT (I feel hot), PAIN (Aches and pain), ABDOMINAL DISCOMFORT (upset stomach), MALAISE (it has not been fun) and FATIGUE (been in bed). On an unknown date, the patient experienced MALAISE (felt like trash). At the time of the report, ERYTHEMA ("beat red" face), LIP SWELLING (swollen lips), SWELLING (Swollen neck and chest), FEELING HOT (I feel hot), PAIN (Aches and pain) and ABDOMINAL DISCOMFORT (upset stomach) had not resolved and MALAISE (it has not been fun), FEELING ABNORMAL (feel trash), MALAISE (felt like trash), HEADACHE (headache) and FATIGUE (been in bed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product also includes  blood pressure pills and magnesium potassium Treatment information was provided as Prednisone, Benadryl,  Epinephrine from emergency room visit   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up received on 12-May-2021 and contains Significant information
awakened w/hives head to toe;on amoxicillin for strep;seen by MD dx as hives not a measles rash;unable to verify amoxicillin allergy vs rxn to vax;
Mom reports "unconscious x 2 min" with associated decreased tone. No fever. No sz activity. Mom did not call office, let us know at next visit. ? hypotonic, hyporesponsive episode.
AFTER PROVIDER FINISHED SEEING PT FOR HER WELL CHILD EXAM APPOINTMENT MD ORDERED MEDICAL ASSISTANT BY GIVING HER A VERBAL ORDER TO GIVE HEPATITIS B VACCINE. PT WAS ADMINISTERED WITH THE SHOT AND MOTHER WAS GIVEN VIS INFORMATION WITH OTHER HANDOUTS IN REGARDS WELL CHILD EXAM FOR HER AGE, 8 MONTHS OF AGE, (THOUGHT PT TODAY 8/3 SHE IS 9 MONTHS). MEDICAL ASSISTANT WAS INPUTTING THE VACCINE INFORMATION INTO PATIENT'S CHART AND NOTICIED THAT THE DATE OF THE VACCINE WAS EXPIRED. PROVIDER WAS NOTIFIED, PER OUR MD OUR DEPARTMENT OF PUBLIC HEALTH WAS NOTIFIED AND TOLD US WHAT TO DO. PATIENT'S MOTHER HAS NOT BEEN NOTIFIED. MD WILL CALL MOTHER'S PT WITH THIS INFORMATION.
Noted swelling and redness with firmness at site which has increased from Quarter size to 12 x 16cm. DX'd as Arthus vs Cellulitis. Placed on Augmentin.
Chest pain lasting for 2 weeks, subsided for 3 weeks then onset of severe chest pain again 5 weeks after receiving vaccine
suspected vaccination failure; have gotten shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient him/herself. The age at vaccination was not reported. After receiving Shingrix, the patient got shingles, 3 times in the year of reporting. The patient asked, if he/she could get the vaccine again. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Approximately 16 hours after receiving 1st Moderna COVID vaccine I became dizzy (could not lie down) and felt nauseous.  Felt unsteady and weak.  Taken to Urgent Care facility where my BP registered 200/100.  I was given nitroglycerin and an aspirin and taken by ambulance to the nearest hospital where I spent two nights.
Pt c/o feeling hot, lightheaded.  Pt skin was flushed and clammy.  Pt was tf into a wheel chair.  Pt tf to med one. Base line vs obtain 78 /66 hr 58 ,98spo2, 20 reps. Pt was given a bottle of water, after 10 min pt side effects past.  Skin coler came back, no longer claims,  last set of vs 98/60 hr 60  spo2 98%  reps 16
Arm was swollen, hot to the touch...client indicated temperature of 102.  Client called her physician....doctor ordered antibiotics/ibuprofen.
Rash - spotty rash about 2 inches in diameter (circular presentation) several different ones on abdomen /underarm  started 09/21 reported to pharmacy 09/22 - rash is not itching or painful - pharmacist got a second opinion from Nurse practioner on duty at clinic recommended benadryl . Pharmacist reached out to patient later in the evening and pt did say that benadryl was helping
Rash reaction. Patient is allergic to eggs. Her allergy doctor ok'd shot for Influenza and H1N1.
I felt pain from the injection, light headed and nausea right away and all of that continued for 4 days. Within hours I felt fatigue, achy all over like with mild joint pain, and developed a headache,; I felt pain from the injection, light headed and nausea right away and all of that continued for 4 days. Within hours I felt fatigue, achy all over like with mild joint pain, and developed a headache,; I felt pain from the injection, light headed and nausea right away and all of that continued for 4 days. Within hours I felt fatigue, achy all over like with mild joint pain, and developed a headache,; I felt fatigue; Achy all over like with mild joint pain; Achy all over like with mild joint pain; headache; This is a spontaneous report received from a contactable consumer (patient). A 57 year old female consumer received first dose of the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6204), via an unspecified route of administration on 23Mar2021 12:30, as SINGLE DOSE for COVID-19 immunisation. Patient medical history included celiac disease and hashimotos thyroiditis. The patient concomitant medications were not reported. It was reported that the patient cannot tolerate gluten or any grains and codene makes her sick. Prior to vaccination, patient was not diagnosed with COVID-19. After the vaccination (23Mar2021, 12:30), the patient felt pain from the injection, light headed and nausea right away and all of that continued for 4 days. Within hours patient felt fatigue, achy all over like with mild joint pain, and developed a headache, those also continued for 4 days. Patient still feeling tired on the day of this report. Since the vaccination, the patient not tested for COVID-19. Patient not received treatment for the events. At the time of this report event feeling tired was not recovered and other events were recovering.   No follow-up attempts are needed. No further information is expected.
I went in for the flu shot I do not know which one they administer but the information can be provided by office. Within an hour I begin feeling very run down. I went to bed and woke up with a fever two hours later, within minutes I had severe vomiting and diarrhea, the vomiting persisted for one hour, the diarrhea for 12 hours. After about 24 hours my mild fever subsided and the symptoms started going away. After about 36 hours I felt comfortable enough to function lightly ...normally again.
Delayed menstrual cycle (has not recurred as of 4/6) w/ attendant hormonal symptoms; cramping, low back pain, fatique, headache.
Rashes, hives on arms and neck, none in the trunk of her body. Hives developed in the pm the day of vaccination. Advised BENADRYL. RN 5/6/2013 retrurned for Tdap; recovered no visible hives or rashes.
Initial information received on 10-Dec-2018 regarding an unsolicited valid serious case received from a pharmacist. This case involves a 71 years old female patient who experienced lump at injection site, unable to sleep, pain rating a nine of scale of zero-ten lasting all day but worse overnight and it was radiating through her upper arm and cellulitis, while she received vaccines ADACEL and PREVNAR 13. The patients past medical history, medical treatments, vaccinations and family history were not provided. On 10-Aug-2018, the patient received a dose of suspect ADACEL lot number U5850AA (Expiry date 10-Aug-2019) via intramuscular route in the left deltoid. On 10-Aug-2018, the patient received a dose of suspect PREVNAR 13 (lot number and Expiry date unknown) via unknown route in the right arm. On an unknown date, the patient developed a non-serious a lump at injection site (vaccination site mass), sleep (sleep disorder), pain rating a nine of scale of zero-ten lasting all day but worse overnight and it was radiating through her upper arm (Pain) and serious cellulitis following the administration of ADACEL and PREVNAR 13. The event of cellulitis was assessed as medically significant. It is also a case of actual medication error due to inappropriate age at vaccine administration. (Other relevant tests included No lab data.) Final diagnosis was cellulitis, radiating pain, unable to sleep and lump at injection site. The patient was treated with IBUPROFEN, AUGMENTIN (875mg/125mg) 1 tablet BID for 10 days for a total of 20 tablets) and topical BENGAY type product. The event outcome was unknown for all events. 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 and Module VI of the 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. List of documents held by sender: none. Sender's Comments: This case involves a 71 years old female patient who experienced cellulitis, lump at injection site, unable to sleep, pain radiating through her upper arm post vaccination with ADACEL and PREVNAR 13. Time to onset is unknown. There is, however, no information regarding patient's medical condition at time of vaccination, site of cellulitis, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies. There is a possibility that the cellulitis is due to a pre-existing nidus of infection or introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccines cannot be individually assessed.
h/a, flushing, lightheadedness, n/v, itching, upset stomach, lower back pressure, insomnia sudden onset of these s/s; then were on/off next 3 days; took Ibuporfen & Entex LA;
Swelling, redness on left thigh by injection site, Tx: cold compress, Ibuprofen, Benadryl
Received primary SPV on 5/10/2011. 24-48 hours later: <1hr Chest ache/pressure at rest described as "2 hands grabbing at lower chest" 24 hours after vaccination; and later a 2-3 hour ache to 2-4th ICS rt side of sternum 48 hours after SPV which resolved with activity. Went to ER on 5/12/11 with normal EKG and CXR. Released with dx of chest pain-resolved. SM sent to clinic by immunization clinic for VAERS and f/u evaluation of his chest pressure. He has had no recurrence of this discomfort, this SM did report 2-4 day history of light am cough prior to vaccination (?URI vs allergic rhinitis PND?).
Maternal grandmother described staring spells which lasted 2 weeks after visit.  She states they were "just like patient's mother's absence seizures caused by her DTP vaccine that she grew out of"  No report to us of these.  Spells until 1-13-09.
Felt slightly lethargic; 18 weeks, 5 days pregnant and received the Afluria inactivated flu vaccine; This non-serious spontaneous case, initially received from other non-health professional (consumer), on 02-Oct-2018, concerning a 24-year-old, adult, female pregnant patient.  The patient had one previous pregnancy. No still birth or miscarriage and no birth defect or congenital anomaly occurred during the previous pregnancy. The patient's current condition included depression and post-traumatic stress disorder (PTSD). The patient's concomitant medications included Wellbutrin (bupropion hydrochloride) and Prenatal vitamins (minerals nos, vitamins nos) for unknown indications. The patient did not use any contraceptive.   The patient's last menstrual period (LMP) date was unknown.  On 02-Oct-2018, at gestational age of 18 weeks and 5 days, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, anatomical location: right deltoid, batch number: YF40408, expiry date: 30-Jun-2019 and route of administration: not reported) (explicitly coded as vaccine exposure during pregnancy) for protection against seasonal influenza.  On the same day, after the vaccine administration, the patient felt slightly lethargic and quickly resolved from the event.   The estimated date of delivery (EDD) was reported on 01-Mar-2019.  Update received on 30-Oct-2018: Non-significant case correction (IRD: 02-Oct-2018): The phrase and felt' was changed to experienced' in the case comment. The phrase ' The causality of the event lethargic was changed to ' The causality of the event lethargy' in the case comment.  No changes were made in the narrative.  Non-significant follow up received from the reporter on 08-Jan-2019: It was reported that, the patient was not enrolled in the pregnancy registry. The reporter also confirmed that, the attempts to reach the patient had exhausted and no further follow up would be conducted. Hence, this case was considered as lost to follow up.; Reporter's Comments: A 24-year-old female pregnant patient was administered Afluria Quadrivalent (vaccine exposure during pregnancy) and experienced slightly lethargic on the same day after vaccination with suspect vaccine Afluria Quadrivalent. The company assessed the causality of the event lethargy as related due to the plausible temporal relationship between the event and suspect vaccine. The company assessed the causality of the event vaccine exposure during pregnancy as not related to the suspect vaccine considering the event as special situation.
Exactly 1 week later have extreme swelling, redness, soreness at the injection site.  Enlarged area feels warm to touch.
Complete loss of speech within two days after vaccination. The day after the vaccine, I was only able to speak for about 20-30 minutes before my voice tired-out. The day after, I was completely mute. To this day, my speech has still not returned. In addition to loss of speech, I have had a series of severe and debilitating neurological and autoimmune type issues that have grown in number and severity over time and still continue to this day. This left me completely bedridden.
Case number PHEH2014US019648 is an initial spontaneous report received from a nurse on 26 SEP 2014. This report refers to a 40 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with season influenza vaccine (other manufacturer and batch number: not reported) on 17 SEP 2014. It was reported that she was inadvertently administered a second dose again with FLUVIRIN 2014/2015 (batch number: 1411901) intramuscularly on 26 SEP 2014. No adverse reaction was reported following the maladministration.
Immediate local reaction within 3-4 minutes with warmth, swelling, erythema. No systemic symptoms. Thigh swelling slowly resolved over 3 days
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of improperly stored GARDASIL (lot # H017698, expiration 02-JUL-2015) (dose unknown), intramuscularly. No adverse effect of the patient has been reported. This is one of several reports received from same source. Additional information has been requested.
40 years old female called to report an adverse reaction after she received her first moderna dose on 04/22/2021 @1500. patient reported that on 04/29/2021 her arm was warm, red, and itchy at the site of the injection. patient reported no past medical history. patient reported no current medication. patient reported no allergies. patient was instructed to take benadryl to help with the symptoms, patient was instructed to seek medical attention if the symptoms got worse.
Successive severe migraines- not typical of my usual migraines. My usual medications are not working
- Intermittent tachycardia and heart palpitations, gradually building to intense chest pains lasting for months and severe bouts of tachycardia (sudden resting heart rate of 140-150 BPM) lasting for several hours at a time, resulting in cardiology POTS diagnosis  - Blood pressure instability - Persistent dizziness, lightheadeness, spacial disorientation, and vertigo - Neuropathy (numbness and tingling in extremeties) - Blurry and double vision - Nausea and heartburn - Rapid drop in ferretin and sex hormone levels - Insomnia / jolting awake at night
PT FELT A SHARP PAIN RIGHT AFTER THE INJECTION FOLLOWED BY REDNESS AROUND 10 PM. PT TOOK A BENADRYL AND HAD TO WAKE UP AT 6 AM  DUE TO PAIN AND SWELLING. THE FOLLOWING DAY PATIENT HAD VERY FATIGUE, NAUSEA, BODY PAIN AND DIARRHEA AND WAS DIZZY AND FELL DUE THE DIZZINESS. TODAY IS THE 5TH DAY AND PATIENT STILL FEELS DIZZY AND INJECTION SITE REMAINS VERY RED AND SWELLED.
pt recv vax 2JAN97 & 2JAN97 pt exp low grade temp w/in 1hr, nausea, hot flashes & pain @ inj site or 2 days;
Partial Paralysis in neck and back region on left side with recurrent muscle fatigue. Major symptom subsided on the 24th, but continued muscular weakness and pain took several months to dissipate. Fatigue and lack of mobility persist to date. Dx: pinched nerve. Receiving physical therapy.
pt recvd vax 9FEB93 & the same day devel low grade fever, n&v, malaise; no further details were provided;
Patient was found to have a small abdominal aortic aneurysm which was enlarging in size. It was recommended he undergo endovascular repair. Patient tested positive for COVID at pre-operative testing, reported in progress note on 4/20/21