chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain; Chills; Injection site pain; Pyrexia; This case was received via VAERS (Reference number: 0931176) on 30-Mar-2021 and was forwarded to Moderna on 30-Mar-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Pain), CHILLS (Chills), VACCINATION SITE PAIN (Injection site pain) and PYREXIA (Pyrexia) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol and Hypertension.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN (Pain), CHILLS (Chills), VACCINATION SITE PAIN (Injection site pain) and PYREXIA (Pyrexia). At the time of the report, PAIN (Pain), CHILLS (Chills), VACCINATION SITE PAIN (Injection site pain) and PYREXIA (Pyrexia) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other Meds : calcium, biotin, aspirin, Norvasc, Atorvastatin Symptom Text : fever, soreness at injection site, body aches and chills.  These began approximately 6:30pm night of injection, continued into the next day.  Taking advil every 4 hours and this has helped to stop the fever but the rest of the symptoms continue   Reporter did not allow further contact
Narrative:  73 y/o male with hx of resistant UTI, HTN, HFpEF, DM-2, OA and BPH presents from adult living facility for lethargy. Per ED report patient had vomited prior to admission but on further discussion with patient's adult living facility they reported patient had an episode of diarrhea. Per facility patient was normal in AM of 7/6/21. Reportedly the aide went to check on the patient and found him unresponsive and called EMS. Patient had no complaints prior to this episode. On 7/6/2021 pt's lab reported positive for covid infection. Pt was fully vaccinated at facility on 12/31/2020 & 1/25/2021. Pt was started on Remdesivir & dexamethasone and admitted. By the next day pt's medical team had ruled out covid infection and diagnosed UTI complicated by bacteremia. Appropriate antibiotics were started. Pt was discharged to a skilled care nursing facility with continuation of iv antibiotics on 7/12/2021.
At first, just the right arm pain for the rest of the day and into the next day. On Friday morning woke up and my right side of my face was droopy. Felt like I had gotten dentist work done my right side of my face was numb. I had to drink water from a straw on the other side of my mouth. when eating my tongue was number and I could only taste food around my tongue. My right eye was very dry had to keep rubbing it. Right side of my face felt so different and tight too. I also experienced a lot of brain fog too. The following week I could tell my brain was definitely not as sharp I could barely keep up with my work as I have a lot of multitasking to do.
Per patient report she has experienced diarrhea for the past 3 days which smelled to her like metal.
New onset of occasional dyslexia- transcribing numbers and letters from hearing to typing from seeing to speaking from seeing to typing from seeing to writing.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 19Dec2021 (Lot number: PF2587) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unknown if ongoing). Concomitant medication(s) included: ZYRTEC-D. Vaccination history included: Bnt162b2 (previous dose product: COVID 19, previous dose lot number: PFIZER ER8737, previous dose administration date: 06Apr2021 , previous dose dose number: 2), administration date: 06Apr2021, when the patient was 41 years old, for COVID-19 Immunization; Bnt162b2 (Previous dose product: COVID 19, previous dose lot number: PFIZER EN6204, previous dose administration date: 06Mar2021 , previous dose dose number: 1), administration date: 06Mar2021, when the patient was 41 years old, for COVID-19 Immunization. The following information was reported: DYSLEXIA (non-serious) with onset 2021, outcome "not recovered", described as "New onset of occasional dyslexia- transcribing numbers and letters from hearing to typing from seeing to speaking from seeing to typing from seeing to writing.". Therapeutic measures were not taken as a result of dyslexia. No follow-up attempts are possible. No further information is expected. Additional Information: The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with covid prior vaccination. The patient was not tested with post vaccination. The patient reported that new onset of occasional dyslexia transcribing numbers and letters from hearing to typing from seeing to speaking from seeing to typing from seeing to writing. The patient other medical history was reported as none.  Follow-Up (18Jan2022): Follow-up attempts are completed. No further information is expected.
Patient was scheduled for additional (100mcg) dose of Moderna COVID-19 vaccine due to immunocompromised status. Patient received 50mcg dose  instead of 100mcg.  The error being reported at this time: After discovery of the first error, the patient was scheduled to receive an additional 100mcg dose to correct the initial error.  The patient received Moderna 50mcg dose again.
Fever 102.3 into next day, fussy, stuffy nose and cough 9/30/06.
PT RECIEVED COVID VACCINE AROUND 1325, AFTER STATING THAT HER DOCTOR, TOLD HER TO COME HERE TO RECIEVE IT, PREVIOUS HX OF ANAPHYLAXIS QUESTIONED AND PT STATED HAD EXPIRED EPIPEN IN CAR,  PT ADVISED OF S/S R/T ALLERGIC REATION TO MAKE STAFF AWARE OF WHILE WAITING FOR HER 30MIN WAITNG PERIOD.  PT CAME TO THIS NURSE AFTER 10-15 MIN FOLLOWING INJECTION STATING SHE WAS FEELING ITCHY,  HAD PT SIT ON BED WHILE CALLING FOR HELP, HUSBAND AT BEDSIDE, NP CAME OVER RIGHT AWAY, BEGAN TREATING PT, AROUND 1340-NP GAVE BENADRYL 50MG GIVEN TO R DELTOID, PEPCID 20MG GIVEN R DORSOGLUTEAL,  SOLUMEDROL 125MG GIVEN L DORSOGLUTEAL, ALL INJECTION AREAS PREPPED WITH BETADINE PRIOR D/T PT ALLERGY TO ALCOHOL, PT STATED FELT BETTER THEN AFTER ABOUT 2/3 MIN BEGAN COUGHING, C/O CHEST TIGHTNESS,  O2 APPLIED 15L VIA NASAL CANNULA, NP GAVE EPIPEN-0.3MG AT 1400, L VASTUS LATERALIS PREPPED WITH BETADINE, FOLLOWING PT WORSENING SYMPTOMS, VS AFTER INJECTION BP-SYS 120-TAKEN MANUALLY BY NP, O2-99%, HR 98-102,  OXYGEN TURNED DOWN TO 2 L, PATIENT CALLED AMBULANCE TO TAKE PT TO ER, PT ALERT, AWAKE, ORIENTED UPON AMBULANCE ARRIVAL AND ABLE TO MOVE OVER TO STRETCHER WITHOUT ASSISTANCE
Area of erythema of hard induration that measures 3.5 inches by 2.5 inches to the left upper leg. Mother to notify us if symptoms get worse or if new symptoms develop.
Pelvic achiness 18 hours post vaccination.  Having vaginal bleeding/spotting 24 hours post vaccination.  Am currently on beginning of week 3 of birth control pills - normally have no issues with spotting - always very consistant.
Tingling and numbness in the face particularly around the mouth.  Started 15 minutes after vaccination and continues now 6 days later. Does not seem to have abated at all. Face feels flushed all the time.
Information has been received from a registered nurse concerning a retired 75 year old Caucasian female pt with allergies to Zithromax, Lodine, EES, contrast dyes, Relafen and Levaquin and NSAIDS who on 15OCT2003 at 10:30 AM was vaccinated in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. Concomitant vaccine administered on 15OCT2003 at 10:30 AM in the left deltoid included a second dose of influenza virus sAg 3v vaccine inactivated. It was noted that the pt also had her first flu vaccine last year 2002. Concomitant therapy include Toprol XL tablets 100 mg QD, Prilosec 20 mg QD PRN, Diazide 37.5/25 QD, Levoxl 0.88 mg QD, K-Dur 20 mEq QD, Dovan HCT 80/12.5 QD and Lexapro 10 mg, Diovan HCT 80/12.5 QD and Lexapro 10mg. The RN reported that on 15OCT2003 at 18:00 pm (also reported as in the afternoon of 15OCT2003, within three hours of vaccination) the pt started to develop a severe local reaction , which got worse thought the evening. The nurse reported that by the evening the right upper rm was described as swollen, hot and painful and it kept the pt awake all night. The pt used a warm pack with little relief. The nurse reported that when the pt was seen the next AM 16OCT2003 the pts arm had significant swelling with erythema of entire upper arm. The swelling and redness is from the shoulder to the elbow and the arm is tender to touch. It was noted that the pt stated, "hurts so much". It was also noted there was no obvious swelling. While in the office, ice was applied to the site and the pt appeared to be feeling somewhat better. The pt's temperature was taken axillary and oral as 98.9 degrees F. The following lab tests were done and the results reported as follows: PT-10.8, INR 1.07, CBC all normal except HgB 11.9, Hct 36.8, MPV 8.6 all were slightly low). Platelets 170x 10 3U/L. the nurse reported she did not know whether the pt took anything for discomfort. In follow up information it was noted that the pt was instructed to ice her arm, take Benadryl and she was given prescriptions for lorazepam 0.5 1/2 tablet every 6 hours as needed, and Darvocet for pain. It was noted that the pt believed, "this was her fist dose of pneumococcal 23v polysaccharide vaccine ever". The nurse also reported that the patient had a lesser, but similar reaction to the influenza virus sAg 3v vaccine inactivated this year (administered 15OCT2003 in the left deltoid) and to the first dose of influenza virus vaccine in 2002. The reactions to the influenza virus in 2002 were reported as mild rxns, ecchymotic with lump on right arm (also reported as black and blue at the injection site with tenderness). The RN reported that as of 17OCT2003 the pt was improved, and as of 04NOV2003 the pt only had "slight itch in upper arm". The pt had no illness at the time of vaccination. There was no other date at this time. There was no product quality complaint involved. Additional follow up received from the registered nurse confirmed the pt recovered and that the pt has had no problems since 17OCT 2003. Unspecified medical attention was sought. No additional information is expected.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI ACUTE RESPIRATORY FAILURE 1/2/2022 -- RECURRENCE OF SAME SYMPTOMS
The patient did not experience any issues or side effects; expired; This spontaneous report was received from a pharmacy technician and referred to a 24-year-old male patient. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 17-NOV-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milligram, lot #W007035, expiration date: 20-OCT-2023, administered intramuscularly via injection in left deltoid for prophylaxis (strength was not provided). The patient did not experience any issues or side effects (no adverse event, Expired vaccine used). The dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) had not been exposed to any previous temperature excursions and was supported on the Post Expiry Memo Vaccines and Biologics Administered and the appropriate disclaimer was provided to the reporter.
I am have terrible arm redness in the arm that the injection was given.  Redness started next day around mid afternoon, and now 2 days later the redness is spreading rather rapidly.   Pain, some sharp pains come and go.   Next day I also experienced sever heart palpatations and rapid heart beat.
Chief Complaint: Matted swollen red eyes, swollen lips and throat. Got flu shot yesterday feels it may be a reaction to this. Level 3 Ht and wt deferred. Received Fluvax first time yesterday about 3pm--immediately felt unusual. Then about 9pm last pm started with throat itching, swelling, eyes itching, lips swelling, some wheezing. No h.o. asthma. No other new foods/exposures yesterday. Also thinks developing pink eye--both eye matted this am.  OBJECTIVE  TMP:98.00 (36.6 C), PU:82, RS:16, BP:129/77, PA:4, O2:100 gen: nad heent: eye injected; tms normal light reflex au turbinates pale, boggy throat post pharynx hyperemic no exudates neck: supple no adenopathy lungs:cta cor: rrr without murmur skin: lower lip edematous ASSESSMENT   1) allergic reaction to Fluvax [P] ; AUG 26, 2011
Pt immunized & exp induration & pain @ inject site; pain radiating from deltoid to fingers & into neck & face; eyes swollen; treated w/Pred & ATB;
Positive for COVID-19 Disease, Minimal COVID-19 Disease symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for COVID-19 Disease, Minimal COVID-19 Disease symptoms) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced COVID-19 (Positive for COVID-19 Disease, Minimal COVID-19 Disease symptoms). At the time of the report, COVID-19 (Positive for COVID-19 Disease, Minimal COVID-19 Disease symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant products were reported . The patient was treated with OTC drugs at home and did not see a physician.   The patient's spouse reported that the pharmacist refused to schedule the second shot and told them that they have to wait 90 days before getting the second dose.  Company Comment: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Significant Follow up received : patient initials added; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable.
BELLS PALSY; INDEX AND MIDDLE  FINGER NOT FUNCTIONING / BENDING PROPERLY; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 21-MAR-2021 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 06-MAY-2021, the patient experienced index and middle finger not functioning and not bending properly. On 07-MAY-2021, the patient experienced loss of facial muscle activity, loss of mouth muscle activity (Bells palsy) and was unable to suck on a straw. No medications were taken at that time. Patient consulted a health care provider who refereed a neurologist. The neurologists after seeing also referred the patient to the emergency department to get a computed tomography scan. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bells palsy, and index and middle finger not functioning / bending properly. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210527130- Covid-19 vaccine ad26.cov2.s-Bell's palsy. This event(s) is considered unassessable. The event(s) 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(s).
Wheezing, cough, hives all over legs and upper torso (back and front).
The patient came in and showed that her  upper right arm (bicep area) was red and warm to the touch, Said that it started at the injection site and has gotten worse
9/20/05 Local school nurse called to say child has developed a "chicken-pox" type rash on arms. Family phone interview revealed that rash was first noticed by family on 9/19/05, as a small red "ball" shaped rash on her arms and back. No fever, pain or malaise after vaccines. As per phone interview with father on 9/22/05, child was seen by doctor that day and diagnosed with an allergic reaction to a food? she ingested. She was prescribed a cream to apply to the rash. No other family members are ill or with rash.
Patient says she has felt very unwell since having the vaccine and that her joints were extremely painful. She is progressively improving however.
Initial information received on 25-Jun-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a four-years old patient (gender not reported) who received a IPOL from a IPOL shipment should be returned due to it being in transport a day longer than it should have, no adverse event. This is the case of actual medication error as the vaccine was administered to the patient, which was incorrectly stored. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On an unknown date, the patient received a dose 0.5 ml of suspect IPOL lot N1K92 via unknown route in unknown administration site. Caller reported that by the time they received notification that their IPOL shipment should be returned due to it being in transport a day longer than it should have, they had administered 5 doses to patients already. All of the patients were 4 years of age. It is unknown who administered each dose. There were no adverse reactions reported for any of the patients who received the doses. The doses were administered on June 8th, June 12th, June 13th, June 14th, June 18th and June 21st. Caller stated they were aware that the parents will have to be notified and the children will have to be re-vaccinated. Caller stated that she had already talked to someone about returning the shipment.  Lab data and corrective treatment: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Documents held by sender: none.
She reported pain all the way down her shoulder to her wrist. Reported about 2 weeks after the shot. Her arms feel really heavy (right). Can't raise her arm over her head. Tried TYLENOL/MOTRIN but not getting better.
PT STATES HER EYES WAS HURTING, SEEING RED, BLOOD CAME OUT OF NOSE WHEN SNEEZING. FEELS LIKE NERVE PAIN IN GUMS/FACE AND THROUGHOUT INJECTION ARM.
tested positive for COVID19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID19) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced COVID-19 (tested positive for COVID19). At the time of the report, COVID-19 (tested positive for COVID19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, SARS-CoV-2 test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment related information was reported. Patient wanted to know if patient could go ahead and get the second dose for which patient was due on 20-Apr-2021.
pt recvd vax 13APR94 & mom gave APAP every 4 hrs that day; pt woke 14APR94 w/generalized rash & hives over torso & arms; edematous, erythematous area to the lt deltoid area is raised & hot to touch; pt was brought to clinic on 18APR94 hives
At 6:00 PM 3/12 I began to feel slightly dizzy. It did not effect my ability to stand or move around very much, but my head did feel strange and if I turned to quickly I would need a second to gather myself. However, it was not severe enough to force me to sit or lay down. By 7:00-7:30 I began to feel hot and uncomfortable and I took my temperature at 7:30 and I was running a low grade fever at 99.8 degrees F. I began to feel very fatigued and was in bed by 9:00 PM. I woke up feeling fine and my temperature at 7:00 AM 3/13 is 97.8 degrees F. My only possible side effect this morning (3/12 as I write this) is that I am mildly stiff, mostly in my left arm, neck, and back (the side of the injection site). Despite the mild fever I did not feel any nausea, nor did I have difficulty breathing. Overall the side effects were mild but uncomfortable.
COVID Vaccine - Administration to minor (under 18) that was brought in by parent (MD) under and DOB was noted as 18, not 17. Informed by local county vaccine administrator of error when parent wanted follow up for 2nd dose.
No adverse effects reported; a 16 year old female inadvertently administered one separate dose each of ZOSTAVAX; ZOSTAVAX administered were expired; Information has been received from a pharmacist referring to a 16 year old female patient. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant therapy included sterile diluent.  On 22-MAR-2019, the patient was inadvertently administered one dose of zoster vaccine live(ZOSTAVAX) 19400 plaque-forming unit (PFU) (lot # N025568, expiration date 08-DEC-2018; dose and frequency were not reported) subcutaneously for prophylaxis (inappropriate schedule of vaccine administered and expired product administered). No adverse effects were reported in patient.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-1904USA003352:
This spontaneous report as received from a pharmacist refers to a 59 year old female patient. The patient had no pertinent medical history. The patient had no drug allergies. On 13-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # not reported) (strength and total daily dose not reported). Concomitant therapies included alprazolam. It was reported that the patient had redness and pain at injection site on an unspecified date in approximately May 2013. The patient sought for medical attention by visiting her physician on 16-MAY-2013 and was prescribed VALTREX, prednisone and CIPRO (as treatment). The patient also stated that she "had blisters drained" and was still feeling ill. It was unknown as to what he blisters were or where on her body. The patient was not recovered. Additional information has been requested.