chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first dose more than 35 days ago; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose more than 35 days ago) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A20A-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose more than 35 days ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose more than 35 days ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concurrent and treatment medication was reported by patient. Her second dose was scheduled for 08 Sep 2021.
Patient described reaction as "Covid arm" (redness, swelling, and warmth at injection site)
This spontaneous report was received from a certified medical assistant and refers to a 3 months old, female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 22-APR-2016 at 12:37, the patient was vaccinated with improperly stored first dose of ROTATEQ lot# L033543, expiry date 30-MAY-2017, orally (dose was not reported). No adverse symptoms were reported. Administered vaccine experienced temperature excursion of 34 Fahrenheit for a total time of 65 hours. There was no previous temperature excursion. Digital data logger was not involved. This is one of several reports received from the same source. Additional information is not expected, as all scheduled correspondence was received.
Narrative:  Timing ERROR only, 2nd dose given 64 days after 1st
Fever & chills overnight, difficulty sleeping. Continued fever & chills the next day with fatigue, mild headache and muscle aches, but all diminished as the day progressed. Better on 2nd day with only slight fatigue and muscle ache remaining.
Rash across bilateral shoulder blades that looked like acne, spread through her entire back and up through her waist by the morning, a few spots on her face and on her chest into Monday.
fever, genera feeling of unwellness. That night had extreme nosebleed causing puddles of blood in her bed and then bathtub.
Initial misuse report received from a nurse practitioner (NP) on 02-Oct-2013: The 06-years-old patient had received FLUZONE ID (dose unknown). No adverse event was reported. List of documents held by sender: none.
moderna covid-19 vaccine EUA--brain fog/weakness/joint pain/very tired/headache for about 8-12 hours when woke up the day after second vaccine, (first dose 1/6/2021 and second 2/3/2021)
Inflammation of knees; Pain in his knees; This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (Inflammation of knees) and ARTHRALGIA (Pain in his knees) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (Inflammation of knees) and ARTHRALGIA (Pain in his knees). The patient was treated with PREDNISONE for Inflammation, at a dose of 1 dosage form. At the time of the report, INFLAMMATION (Inflammation of knees) and ARTHRALGIA (Pain in his knees) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient had been having a problem with his knees for 6 months to a year before getting the vaccine.  Concomitant product use was not provided by the reporter.
prolonged crying (screaming) began 2-3 hr p/inj; cont for 4 1/2 hr; temp was 97.4R @ time of inj & elevated to 101R x 24hrs; mom called MD & was advised on APAP dosage;
21AUG93 rash on back, face, neck; 22AUG93 temp of 101.4 contacted MD told it was reaction advised APAP; 23AUG93 4AM convuls transported via ambulence to hosp;
Rph forgot to salvage Covid 19 Pfizer vaccine, which was diluted at 2 pm on Wednesday 2-2-2022.  The bottle with 3 doses remaining was still refrigerated.  The next day, Wednesday 2-3-2022  another pharmacist drew a dose from this expired vaccine vial that should been salvaged the previous day unknowingly administered dose to patient.  The booster dose was administered to patient approximately around 3:25pm Thursday 2-3-2022.    I called patient at 6pm on Thursday 2-3-2022 to informed him about the mistake that I made.  I was not able to speak to the patient therefore I left  a message with the patient.    Friday 2-4-2022 my pharmacy manager called Biontech/Pfizer manufacture to find out what is the next step for this patient.  They informed us that they will send more information about this case to us.     Friday 2-4-2022 around 10:34am,  I called the patient and be able to speak with him on the phone.   He does not any side effects, expect with arm soreness.   He is doing great and has nothing to complaint.
arm is real red around where the shot was. It's sore and swollen; real red around where the shot was; arm is real red around where the shot was. It's sore; achy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm is real red around where the shot was. It's sore and swollen), VACCINATION SITE ERYTHEMA (real red around where the shot was), VACCINATION SITE PAIN (arm is real red around where the shot was. It's sore) and MYALGIA (achy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025821A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced PERIPHERAL SWELLING (arm is real red around where the shot was. It's sore and swollen), VACCINATION SITE ERYTHEMA (real red around where the shot was), VACCINATION SITE PAIN (arm is real red around where the shot was. It's sore) and MYALGIA (achy). At the time of the report, PERIPHERAL SWELLING (arm is real red around where the shot was. It's sore and swollen), VACCINATION SITE ERYTHEMA (real red around where the shot was), VACCINATION SITE PAIN (arm is real red around where the shot was. It's sore) and MYALGIA (achy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow up information received contains No New Information.
Red area, raised size of apple, non tender appearing 2 days following immunization. Gave BENADRYL & told to do cold compresses. Called pt. 9-6-11 he is doing fine. No nodule now. Only slight bruise.
full arm pins and needles every day; got the shot almost a year later; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 56-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Feb2022 administration time AM (Lot number: FK9895) as dose 2, single for COVID-19 immunisation. Vaccine was not administered at military facility. Relevant medical history included: "thyroid hypo", start date: 1991 (ongoing). Concomitant medication included: SYNTHROID taken for hypothyroidism, start date: 1991 (ongoing). Vaccination history included: BNT162b2 (dose 1, single, administration time AM, right upper arm, intramuscular, lot no: ER8371), administration date: 18Apr2021, for COVID-19 immunisation, reactions: "that I had nerve damage", "pins and needles from my shoulder 2 finger tip". The patient did not receive prior vaccinations within 4 weeks. The following information was reported: PARAESTHESIA (disability, medically significant), outcome "not recovered", described as "full arm pins and needles every day"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 03Feb2022, outcome "unknown", described as "got the shot almost a year later". The event "full arm pins and needles every day" was evaluated at the physician office visit. The patient did not undergo any relevant tests.  Clinical course: Patient only got the shot (almost a year later) because she had to. She would lose her job if she did not. Her doctor said she did not qualify for a medical exemption. While the second dose did not make it worse. She still had full arm pins and needles every day. Frequency and intensity change but she never skipped a day.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200175812 same reporter/patient/drug/different dose/event
9/5 - Soreness around inj. site - iced; 9/6 - Day-five - PM- took Ibuprofen - slept fine; 9/7 - About 11 AM swelling began R upper arm, breast and up into neck pain. got antibiotics.
High fever beginning at midnight after a late afternoon shot.  Shivering and overall body cramping. Headache, panting, stomach ache, muscle pain, weakness, upset stomach, constipation - no diarhhea or vomiting.  Continue for 30  hours nearly unconscious, complete zombie, no thoughts, clenched in shivering position despite blankets.  36 hours later (now) just achey all over, finally had a b.m., no fever, all other symptoms gone.  Although I was given the normal warnings, I never expected the knock-down all-out severity of my reaction., which is why I am reporting.
pt found out was pregnant 3 days p/recv vax-has no abn events so far-no problems so far
POST VACCINE, PATIENT NOTED TO HAVE TREMORS, AND NEAR SYNCOPAL EPISODE. ASSISTED TO FLOOR, FEET PLACED ON CHAIR, DID NOT LOSE CONSCIOUSNESS. ASSISTED TO STRETCHER, TAKEN TO OBS WITH DAD, PLACED IN TRENDELENBERG, REPORTS SLIGHT RELIEF (SPECIAL NEEDS). ALSO REPORTED NAUSEA. VSS THROUGHOUT EPISODE. ONCE S/S IMPROVED, SAT UP AND SNACK PROVIDED. ONCE S/S RESOLVED, ESCORTED VIA WC WITH FATHER TO EXIT WITH NO ISSUES AT 1245. 1140 LYING BP 110/76 HR 98 RR 22 SATS 99% RA 1200 SITTING BP 108/75 HR 90 RR 20 SATS 98% RA 1230P STANDING BP 110/72 HR 88 RR 20 SATS 99% RA
No adverse events noted. Patient received incorrect vaccine. Was due for MMR but received MMRV.
Chills (to the point of shaking); Nausea; Headache; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3248) via an unspecified route of administration in the left arm on 24Mar2021 at 13:00 as a single dose (at the age of 49-year-old) for COVID-19 immunisation. Relevant past drug history included received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3248), via an unspecified route of administration in the left arm on 03Mar2021 at 13:30 (at the age of 49-year-old) as a first single dose for COVID-19 immunisation. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications within two weeks of vaccination included vitamin C (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN), all for unknown indication and from unknown date. On 25Mar2021 at 01:30, the patient experienced chills (to the point of shaking) for 3 hours, nausea, headache and body aches. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills (to the point of shaking), nausea, headache and body aches were resolving.   No follow-up attempts are needed. No further information is expected.
6 month old male infant vaccinated with dose #3 of ROTATEQ under FDA IND protocol 13843 - normal, control infant-  developed daily fevers up to 102.3 degrees F. from 9/23/10 through 9/25/10 when tmax was 100.5 degrees. He as also fussy but consolable during this time from 9/23/10 through 9/26/10. All symptoms resolved without effects. No hospitalization occurred. The patient was also vaccinated on the same day with IM PENTACEL, HEP B vaccine and PREVNAR 13. It is possible that the fevers and fussiness if from the rotavirus vaccine, but may also be due to the concomitant other vaccines given on the same day as he had previously tolerated doses 1 and 2 of the ROTATEQ vaccine without noted adverse events.
sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 31Mar2021 as dose 2, single (Lot number: ER8733) at the age of 74 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EN6204, ), administration date: 11Mar2021, when the patient was 74-year-old, for COVID-19 Immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  Additional information: It was reported that, The patient had no problems with the first 4 doses, there was a bit of sore arm and she had less of a sore arm with this one and it was maybe just overnight and by the next night was fine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201241797 same reporter/patient/AE, different dose;
We placed a Inject-safe Barrier Bandage Injection Site bandage when we gave her immunization. She marked her form that she doesn't have allergies to gelatin, eggs or latex etc. On the phone following up with her she stated she has reacted in past to adhesives. She stated she had 2-3 inch red circle that was growing bigger. I asked if she had taken an antihistamine and she stated no but she would.
Paresthesia of all four extremities,  high BP and Pulse, faint, dizziness.
Patient has been having increasing pain in shoulder shot was given in. Dr. has diagnosed problem as tendonitis. Patient has reduced range of motion. Pt is taking Tylenol and Ibuprofen to treat and has arm in sling.
I had serve shaking for about an hour. I has SOB, headache, and back pain. I went to the clinic. They did blood work. They called me later to get to the hospital for what is called d-diner was very high. This can cause blood clots. Do calcitonin was very high that means that there was an infection. I went to the ER. I had 2 CT scan, chest x-ray, and EKG. I was admitted for 4 days. I became confusion. They did EEG, MRI, and lumbar spinal tap. They were unable to determine what is causing this. I was referred to a specialist and he could not determine the cause either.
Vaccine breakthrough hospitalization - SOB with O2 sat 50% when EMS arrived. On non-rebreather satting 70%. Chills, fever, cough, and chest pain. BP 152/79, HR 93, RR 20, SpO2 91%. Had been scheduled to receive COVID mAb day of admission, but clinical course worsened. Admitted to Medical ICU for acute respiratory failure with hypoxia and ARDS secondary to COVID-19. Placed on BIPAP and Rx with Remdesivir, dexamethasone, & tociluzumab. Treated for presumed pulmonary embolism with full-dose anticoagulation. Pt expressed wishes to remain DNR/DNI, ultimately she elected to transition to comfort measures only given worsening hypoxia.
No adverse event; patient was administered improperly stored VAQTA; This spontaneous report was received from a medical assistant, referring to a 16-year-old adolescent patient of unknown gender. The patient's  pertinent medical history, concurrent conditions, drug allergies/reactions and concomitant medications were not reported. On 26-SEP-2019, the patient was vaccinated with an improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) of lot # S007770 having expiration date 24-JUL-2020 (strength, dose, schedule and route of administration were unknown) for prophylaxis (product storage error). The vaccine underwent temperature excursion below 36-degree Fahrenheit/2 degree celsius: 35.4 Fahrenheit for a duration of 10 minutes. There was no previous temperature excursion. There was no involvement of data logger. No product quality complaints (PQC) were involved. There was no adverse event.
Headache & Myalgia missed some time from work the day following second dose due to the above symptoms
15 minutes p/vax exp pain from MMR; 25 minutes p/vax eye swelling, lip turn dark, coughing & difficulty w/throat;
1st dose of Shingrix was 10/05/2023; 2nd dose given 11/21/2023 approx 1 1/2 weeks too soon.
Patient reports feeling "loopy" for 1/2 hour after first dose. Her symptom started 1/2 hr after first dose.
Fever, chills, large induration @ inject site. Wheezing - non threatening. Arthralgia.
Information has been received from the mother of a female child with allergies to soy, milk and eggs.  The mother of the child reported that when the child received the 2 months vaccinations of PEDVAX HIB (OMPC) (manufacturer unknown) and (unspecified) DTaP, she became very fussy, could not sleep, and had blood in her stools.  The child was sought unspecified medical attention.  The patient's mother states that her child had lots of allergies.  It was reported that due to religious reasons the child was not given pork gelatin products.  At the time of the report, it was unknown if the patient recovered.  Additional information has been requested.
Starting 07/20/2022, I felt like I was getting a cold: stuffy nose and mild headache. On 07/22/2022, it started getting worse and I didn't test until later that evening. I ended up testing positive. My wife tested positive for COVID-19 the day prior. On 07/23/2022, I went to a walk in clinic, where they tested me again, and it was positive. They prescribed me PAXLOVID and I ended up starting it that day. I had a stuffy nose, cough and a headache. The symptoms started getting better after I started the PAXLOVID. Last Friday, 08/05/2022, I tested myself at home and was negative. On Monday, 08/08/2022, I tested myself again and was positive. I talked to my daughter, who is nurse, and she told me to stop testing myself. I am feeling fine as of today, just intermittent stuffy nose and cough. I was scheduled for a check up colonoscopy during this time but it was rescheduled due to me having COVID-19.
Parent reports, hot, red, hard swelling from shoulder to injection site on 5-8-14. Seen 5-9-14 area approximately 5 in. in length, skin pink and slightly taut, warm, not hard. No signs of infection. Local reaction at Tdap site.
administered powder reconstituting it with non-GSK diluent; administered powder reconstituting it with non-GSK diluent; This case was reported by a nurse and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number Amva677a, expiry date 30th April 2023) for prophylaxis.   Concurrent medical conditions included allergic rhinitis (had Allergic rhinitis since 26th February 2018).   On 25th August 2022, the patient received the 1st dose of Menveo (intramuscular). On 25th August 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The reporter reported that the patient received Menveo in that administered powder reconstituting it with non-GSK diluent. The patient stated that, still trying to reach to the schedule. All five potential patients were recalled for revaccination. No adverse reactions known. The reporter stated that the system was utilized from 6th September 2022. Diluent would be dispensed with the powder in this machine. RNS to check all vials for vaccines prior to administration. Additional supportive information: Menveo reconstituted with non-GSK diluent instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case was one of 5 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR131200:Same reporter US-GSK-US2022AMR131228:Same reporter US-GSK-US2022124956:Same reporter/ original report US-GSK-US2022AMR131240:Same reporter
Severe ringing in ears for about 24 hrs.  Bad body aches  My head felt like it was going to explode  Spent the day in bed on Thursday until 6:30 pm. Only to go back to bed at 9 pm  Left arm sore and swollen through Friday
fever (101), uncontrollable shaking, muscle spasms-especially legs, thirst, stiff neck and joints  - 4/12/06 Review of 7-page medical record indicates final diagnosis of 'rigors of unclear etiology'. On PE the patient was afebrile with pulse of 101 and 100% oxygen saturation. Treated with IV Ativan, fluids, and rest.
PATIENT SAID SHE DEVELOPED RASH ON LEGS AND SWELLING IN THE LEGS THE DAY AFTER THE VACCINE
He didn't have irritation or redness at the injection site. The next morning at 7:45 am feeling really tired had headache he had a fever of 100. He went to bed his fever worsened that evening (on 7/19 100.4,5:25 PM ET,100.8, 8:30 PM ET ). At that point he was given cold compress to lower the temperature. On 7/20 at 3:23 PM  temperature was 101 and 7:43 PM 103.1. We spoke with his pediatrician was advised to get him a 97.2 degree bath.His temperature went from 102.8 to 100.9.Then on 7/21 he became coherent in a state of confusion I gave him some Advil. Before we got to the hospital his temperature continued to elevate 103.8.  At the hospital around 6:45 pm his temperature read 103.1 when we arrived they gave him Tylenol admitted him right away he was given IV fluids,pulse rate 189, platelets (150 to 112) was dropping and Tylenol was given every 4 hrs. On 7/23 8:24 AM still in the hospital rash started appearing all over his body and white of his eyes (both) developed red veins headache worsened was seen by a Infectious disease doctor. He was discharged on 7/24 diagnosis of Thrombocytopenia, Leukopenia and Acute hyponatremia.
Felt sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Felt sore arm) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jan-2021, the patient experienced PAIN IN EXTREMITY (Felt sore arm). On 04-Feb-2021, PAIN IN EXTREMITY (Felt sore arm) had resolved. Not Provided