chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administration past beyond use date Exp 10/03/21; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration past beyond use date Exp 10/03/21) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration past beyond use date Exp 10/03/21). On 02-Jul-2021, EXPIRED PRODUCT ADMINISTERED (administration past beyond use date Exp 10/03/21) had resolved.            No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-348962 (Patient Link).
CONTACTED BY CLIENT'S MOTHER. CLIENT WAS VACCINATED ON 8-12-11 AND HAS A BASEBALL SIZED RED CIRCLE TO THE BACKSIDE OF LEFT ARM, WHERE VARICELLA WAS ADMINSTERED. THE "SPLOTCHY" AREA WAS 1ST NOTICED ON SATURDAY NIGHT (8-13-11). CLIENT HAS GOOD RANGE OF MOTION, ONLY PAINFUL TO TOUCH. MOTHER ADMINISTERED MOTRIN AND BENADRYL ON SUNDAY NIGHT (8-14-11). PLAN: MONITOR THE SITE IN CASE OF REDNESS/PAIN SPREADS BEYOND EXISTING BORDERS. WILL ICE AND GIVE MOTRIN, BENADRYL PRN. FOLLOW UP WITH PCP IF SYMPTOMS WORSEN.
May have COVID-19; chills; Clamminess; Body aches; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (May have COVID-19), COLD SWEAT (Clamminess), PAIN (Body aches), PYREXIA (Low grade fever) and CHILLS (chills) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced COLD SWEAT (Clamminess), PAIN (Body aches) and PYREXIA (Low grade fever). On an unknown date, the patient experienced SUSPECTED COVID-19 (May have COVID-19) and CHILLS (chills). At the time of the report, SUSPECTED COVID-19 (May have COVID-19) outcome was unknown, COLD SWEAT (Clamminess), PYREXIA (Low grade fever) and CHILLS (chills) had resolved and PAIN (Body aches) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, SARS-CoV-2 test: (Negative) Fairly certain the test result was wrong..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Products known to have been used by the patient, within two weeks prior to the event , included atorvastatin, metformin and vitamins nos. The treatment information was not provided.
pt recv vax 24JUL97 & 9AUG97 pt exp gen itching, a stiff neck & soreness in the joints of hand & wrist;
This spontaneous report as received from a registered nurse refers to her daughter a 32 years old patient with diabetes and unspecified narcotics allergy. The patient was vaccinated with a dose of 0.5 ml PNEUMOVAX 23 (lot number not provided) intravenous or intradermal on 17-JUL-2012. No other co-suspects were reported. Concomitant medications included unspecified insulin and LEXAPRO. On 17-JUL-2012 the patient developed pain and swelling which expanded 3 to 4 inches below injection site area within 1 to 2 hours after administration. The nurse believed that the PNEUMOVAX 23 injection may have been inadvertently administered by intravenous or intradermal route rather than by intramuscular route which may have contributed to the adverse events. The patient had sought medical attention via go to the emergency room and unspecified antibiotics was given for the adverse events. The patient performed hormone and blood tests with no results provided. The patient was recovering from the adverse events. Additional information is not expected.
administered the DTAP-IPV portion of PENTACEL without first reconstituting with the HIB portion, with no reported adverse event; Initial information received on 23-Feb-2022 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves a 4 months old male patient who was administered the dtap-ipv portion of pentacel without first reconstituting with the hib portion, with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(Mrc5)/HIB(Prp/T) Vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine Conj 7v (Crm197) (Prevnar) and Rotavirus Vaccine Live Reassort Oral 5v (Rotateq) for Prophylactic vaccination.  On 21-Feb-2022, the patient received one Dosage form of 0.5 ml, once a day of suspect Pentacel Vaccine (lot UJ569ABA, expiry date: 11-Sep-2022) via intramuscular route in the left thigh for immunization.  On 21-FEB-2022 the patient was administered the dtap-ipv portion of pentacel without first reconstituting with the hib portion, with no reported adverse event (product preparation error) (latency: same day) following the administration of Pentacel Vaccine.  Action taken was not applicable.  Outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Pfizer BioNTech COVID-19 Vaccine EUA Patient received Pfizer Vaccines on 1/29/2021 and 3/2/2021. Presented to emergency department on 7/20/2021 with c/o fever and dyspnea x24 hours. Patient had a chest xray and positive COVID-19 test at another facility prior to presentation. Patient was hypoxic at 85% and started on Nasal cannula O2. Patient was treated with Remdesivir and dexamethasone. Patient expired on 7/31/2021.
no adverse event; Moderna lot #047C22A manufacturer date 3/24/23. Three doses were administered after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna lot #047C22A manufacturer date 3/24/23. Three doses were administered after the expiration date.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 047C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 31-Mar-2023,  after starting , the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna lot #047C22A manufacturer date 3/24/23. Three doses were administered after the expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna lot #047C22A manufacturer date 3/24/23. Three doses were administered after the expiration date.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna lot #047C22A manufacturer date 3/24/23. Three doses were administered after the expiration date.).    No concomitant information was reported. Suspect product dosage text was reported as unknown. The manufacture date was 24-Mar-2023. The unknown vial was initially stored in the refrigerator 07-Mar-2023 and did not underwent any temperature excursions. All three vials remained in the correct refrigerated storage until administration with no temperature excursions. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-720850, US-MODERNATX, INC.-MOD-2023-720851 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720850: US-MODERNATX, INC.-MOD-2023-720851:
Information has been received from a physician concerning a patient who "many years ago" was vaccinated with varicella virus vaccine live. On approximately 01/11/2001 the patient experienced chicken pox. Additional information has been requested.
The day of the vaccine I was very sore for three days. On day 8th I got a really bad reaction. Redness, itchy and burning sensation.
After two days I experienced a loud ringing noise in both of my ears.    It's been over two weeks and the noise has not subsided.      I have a Son that suffers from tinnitus - I would compare the symptoms to those of my son's tinnitus.  I have had to purchase a white noise machine to assist with sleeping.     This is very alarming - had I known of the outcome I would not have taken the vaccine.  I hope this noise reduces over time.    I would be happy to discuss more if requested.
Fainted after vaccination, after fainting - exhibited headache, weakness, nausea, vomiting. Was monitored at office for 45 minutes, then sent via ambulance to hospital.
- Extreme body aches on lower back and thighs/glutes. Could not walk and legs started to cramp for 2 days.  - Face and skin began to turn yellowish in hue (Jaundice)  -Extreme dizziness and feeling of euphoria where I could not stand  -High Fever over 102.5 degrees.
my body aches in joint pain all over; joint pain all over; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (my body aches in joint pain all over) and ARTHRALGIA (joint pain all over) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced MYALGIA (my body aches in joint pain all over) and ARTHRALGIA (joint pain all over). At the time of the report, MYALGIA (my body aches in joint pain all over) and ARTHRALGIA (joint pain all over) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.
CHRONIC HYPOXEMIC RESPIRATORY FAILURE 9/12/2022 DIASTOLIC HEART FAILURE, UNSPECIFIED ACUITY
Patient is a 75 y.o. female patient with history of prolymphocytic leukemia on ibrutinib, breast cancer, IDDM, HTN, depression, OSA who presented to Medical Center with acute dyspnea.   Acute on chronic hypoxemic respiratory failure-resolved SO2 ~60s on-site ; baseline on 3L Due to COVID, possible superimposed bacterial pneumonia CT on admission showed B/L consolidations in lower lobes B/L Intubated in ED MAP (mmHg):  [88-115] 95 Pulm following Extubated  3/24; doing well on RA 3/26 at rest and on ambulation     Septic Shock-resolved P/w fever, tachycardia, resp failure, shock Likely due to UTI mainly; can't r/o superimposed bacterial PNA although less likely WBC wnl; Lactate wnl BCx NTD; UCx as below On Vanc and Cefepime since admission On Levo since admission; off 3/24 am MRSA probe +ve     Covid-19 Virus Infection CAP Date of onset of symptoms: 3/22 Symptoms present on admission: dyspnea Date of covid positive test: 3/22 Vaccination status: vaccinated Imaging: CT as above Oxygen requirements on admission: ventilator Current oxygen requirements: ventilator Medical therapy: steroids; ABx as above MRS Probe +ve Consultants following: Pulm Anticipated special isolation end date: 4/2Acute UTI UA is grossly positive Ucx >100k CRE Klebs susceptible to Cefepime No acute CTAP findings Could change to PO Cipro on dc(End 3/29)   AKI-resolving Developed 3/23 with Cr sharply up to 1.2 from wnl  Likely ATN due to shock Non-oliguric Peaked at 1.4 then improved     IDDM; uncontrolled A1C 6.6 BG >200 here due to steroids Home lantus 35u HS continued Improved   HTN Hold home amlodipine for shock Resumed as BP high   B cell prolymphocytic leukemia Hold ibrutinib for now while critically ill   Chronic pain syndrome Holding home percoset, gabapentin, zanaflex while on ICU sedation, resume as able   Depression Continue duloxetine
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild
15MAR93 pt 100% fine, t96.1 shot given; 16MAR93 noon fever (?temp) grand mal sz; p/ t103.5 R; see-no rx;
chills; headache; muscle aches; intense fatigue; This is a spontaneous report received from a contactable reporter(s) (Physician).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), in Sep2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: Aug2021, for COVID-19 immunization, reaction(s): "Chills", "intense fatigue", "Headache", "muscle aches". The following information was reported: CHILLS (non-serious) with onset Sep2021, outcome "recovered" (Sep2021); HEADACHE (non-serious) with onset Sep2021, outcome "recovered" (Sep2021); FATIGUE (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "intense fatigue"; MYALGIA (non-serious) with onset Sep2021, outcome "recovered" (Sep2021), described as "muscle aches". It was unknown if therapeutic measures were taken as a result of chills, headache, myalgia, fatigue. Additional information: It was unknown whether the patient had any medical history or known allergies. It was unknown whether the patient had other vaccine in four weeks and other medications in two weeks. The patient had no COVID prior vaccination and had not been COVID tested post vaccination. The patient had experienced similar symptoms 1 day after each of the two doses of Pfizer vaccine that lasted only for 1 day each during her primary vaccination sequence of dosing. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Initial symptoms began with pain at the injection site and generalized fatigue.  This developed into soft tissue pain in proximity of the large and small joints which could be elicited further on palpation.  I had eye pain (left more severe than the right) which could be further elicited on palpation, headache, dizziness, chills, and an inability to feel warm.  There was also significant skin sensitivity over the trunk, scalp, and upper extremities and more in the left arm than the right.  The symptoms persisted over the second day albeit at less severity.  Presently on the third day, I am experiencing continued eye pain, mainly in the left eye and mild dizziness.
POST VACCINE, BEGAN TO FEEL FLUSHED, LIGHT HEADED, AND HAD PRE-SYNCOPAL EPISODE, ASSISTED TO FLOOR; SYNCOPAL TREMORS NOTED BRIEFLY. SPONTANEOUS RECOVERY WITH NO S/S UPON ARRIVAL TO OBS VIA STRETCHER. VSS. ESCORTED TO EXIT WITH NO ISSUES ONCE S/S RESOLVED AT 1700. 1631 BP 160/88 HR 70 RR 12 SATS 100% RA 1653 STANDING BP 144/90 HR 80 RR 16 SATS 98% RA
arm stiffness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (arm stiffness) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (arm stiffness). At the time of the report, MUSCULOSKELETAL STIFFNESS (arm stiffness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter. No treatment information was provided.
pt recv vax 14SEP98 & noted to be cranky w/temp @ home right p/vax;given meds fever resolved;awoke 10PM w/fever;child stood up fell & hit head on TV;child started to sz;taken to ER-intubated;
Right arm with 2.5-3" long 1.5-2" wide reddened, warm to touch, developed the day after vaccine. Seen by OHS rec. Ice, Benadryl, Antihistamine.  Today she returned with decreased swelling & redness.
Patient reported a 1 inch by 3 inch red "line" about a few inches underneath the site of injection that is very warm to the touch and slightly painful
Site: Pain at Injection Site-Severe, Systemic: SWOLLEN LYMPH NODES-Severe, Systemic: Lymph Node Swelling-Severe, Additional Details: PATIENT VISITED HER DR SINCE SHE HAS BEEN EXPERIENCING PAIN IN HER BREAST AND WAS TOLD THAT HER LYMPH NODES ARE SWOLLEN DUE TO COVID VACCINE.
Pain and tenderness at injection site following 12 hours post-vaccination. Head fogginess, difficulty focusing on tasks, and light-headedness began around 9:00AM on 1/8/2021, and progressively worsened throughout course of day. Severe body aches and joint pain (entire body) with severe malaise and fatigue began later that evening about 8:00PM on 1/8/2021 until about 12:00PM on 1/9/2021. Took Tylenol 500mg as indicated for 24 hours. Symptoms resolved by mid-afternoon 1/9/2021.
Pt recv vax on 3/2/98; on 3/7-3/8/98 pt exp vax site rash to torso & other arm & pressure behind eyes; tx=antimalarials
She had a gradual onset of symptoms after 2nd dose of moderna, beginning with bilateral shoulder pain/stiffness and elevated inflammatory markers. She was diagnosed by rheumatology with rheumatoid arthritis with an elevated RF approximately one month after 2nd dose. She was tried on Humira and Enbrel with gradual worsening proximal muscle weakness. She was then found to have a CPK of approximately 7000. She was admitted to the hospital with weakness and decreased NIF. Currently receiving IVIG and IV steroids.
NauseaVomiting, brain fog, feels hot no fever Narrative: Received 2nd covid vaccine 2/4/21 and he is feeling brain fog, nauseated, and don't feel well, feels hot but no fever temp normal
10 hours after vaccination I had chills, fever of 101, aches all over. 12 hours later fever was down to 99 but very tired and no appetite that lasted another day.  Today, 2/18/2021) I am still tired and now short of breath.
Mother called and report a "spot" on child lower leg that progressed to a blister on 9/22/04 and 9/23/04 and then dried up. Low grade fever also accompanied that. Report also follow up October that vaccination site in RUA continued off and on to be red and itchy. This continued through November 20th when out of state the child broke out with "pimple looking rash" and a fever that would come and go until 11/27/04. Saw a doctor with this on 11/23/04 who reported this to be chickenpox "an odd case". Child now without rash, but continues to be itchy along waist line, arms, legs and injection site and run low grade fever off and on. Mother concerned.
Pt received a flu shot - Fluzone - 10/22/07 at 1100. She states later the same day, it became swollen, painful, not itchy. When I saw (L) deltoid site on 10/24, it was mildly red 9cm x 7cm area, faintly raised, no undue warmth of area, tender or palpation.
Information has been received from a mother concerning her 7 year old daughter who was vaccinated with a dose of varicella virus vaccine live. It was reported that on 5/21/2005 the patient developed a mild case of breakthrough chickenpox while sitting next an unvaccinated child. The patient had less than 15 red raised areas that resembled bug bites, 1 behind her ear, 2 under her arms, a couple on her belly, and 1 on her bottom. it was noted that the mother felt it was hard to tell that she even had chickenpox. It was noted that patient saw a physician who diagnosed the chickenpox. On 5/21/2005 the patient had a fever and by 5/24/2005 she was recovered. Additional information has been requested.
It has been a while since I got my third dose and my arm started bothering me months down the road. When I went to have my fourth dose my left arm where I had taken all 3 doses before was hurting so I had the fourth shot in my right arm.  The pain can be acute and it comes when moving my arm a certain way. Something in there is damaged and I blame it on the Covid vaccine since I have never had a muscle problem like this in my life and the area where it hurts is right over the injection area.  It is a pain that I hoped I could work out, but it feels as if the muscle itself is damaged and will not repair itself.  It doesn't hurt all the time and I still use the arm. Only certain stretches I make to reach or wash the opposite armpit lets say, I get a sharp pain there. (I will say that you might find another report on me for a full body rash from the covid. My personal opinion is the vaccine may have interacted with a prescription drug I took during the same period, but that was the other report I did to you on the rash. And, I sent you a follow-up after we got the rash under control with a mild form of steroids.) So, this report is on the muscle which seems to have been damaged. I lay on the left side where the first 3 doses were given. I am quite heavy at this time and losing but the weight could have something to do with it. I also have high blood pressure.
06/02/2021 I had severe headaches with ocular headaches and kaleidoscope vision, flu-like symptoms with chills but no fever. Went to my doctor and saw the PA to get blood work done. Sedimentation rate and platelet count was low. X-ray was done as well but no results were given. Was advised to eat better and exercise to stave off issues. Later, saw my PCP and was advised a treatment would be needed to determine a suspected diagnosis. High doses of prednisone over a 10mo. Period to determine if polymyalgia rheumatica was the issue I was having, however, I was not willing to go through such harsh treatment. Offer to refer to other doctors or anti-inflammatory treatment and I chose the latter. Control has been established for this issue but I still have yet to recover.