chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lymphoproliferative disorder; Enlarged lymph glands supraclavicular; This a spontaneous report from a Pfizer employee received from a contactable pharmacist. A 14-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot Number: ER8735) via intramuscularly administered in left arm on 22May2021 15:00 as single dose for COVID-19 immunization. Medical history included prior heart transplant and patient had known allergies to Amoxicillin, tree nuts/peanuts. Concomitant medications within 2 weeks of vaccination included Cyclosporine, Prednisone, Azathioprine and among other supplments. On 09Jun2021, the patient experienced lymphoproliferative disorder and enlarged lymph glands supraclavicular. The patient was hospitalized for both the events for 6 days. The outcome of the events was recovering. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (Nasal Swab) was negative on 04Jun2021. The patient had enlarged lymph glands supraclavicular in addition to lymph tissue in chest based on CT scan. It was reported that the events may have started prior to vaccine administration however reporting this as vaccine was administered in the weeks prior to enlarged lymph being reported by patient. The most recent COVID-19 vaccine was administered at public health clinic. The patient receives no other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Patient visited Emergency room/department or urgent care for events. Outcome of events was recovering.  Information on batch/lot no. were available. Further information has been requested.; Sender's Comments: Based on temporal relationship, there is reasonable possibility of causal association between the event Lymphoproliferative disease and Lymphadenopathy and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Started with red round circle and has increased to larger area of arm being red and warm. Slight itch. Patient has no pain, is going to take allergy medication and anti-inflammatory to help with reaction. Knows to contact MD if anything changes.
mom noticed swelling and redness in right thigh at injection site, area spread medially the next day 08/30/2010 in which he was examined in the clinic which showed an 11cm by 8.5cm area of redness
Pt. received vaccine on 3/10/12 and presented to pharmacy on 3/16/12 that her arm was red, swollen, hot to touch, & had a lump. Pt. contacted MD & he said must be a side effect & to use warm compress.
Woke up with bilateral angioedema of eyes, hives over entire body. Received Benadryl at home and given a prescription for Atarax
Information has been received from a medical assistant concerning a 9 weeks old female with no pertinent medical history and no known allergies who on 18-FEB-2010 was vaccinated with the first dose of ROTATEQ (lot number 664783/1211Y). The patient received 4 drops from the first tube and spit it up. The remainder of the dose was not given to the child. The medical assistant attempted to give another tube of vaccine and gave 2 drops when the patient spit it up. This second tube was not finished. Concomitant medications included 3 other unspecified vaccines on the same day. Medical attention was sought via office visit. There was no lab studies performed. On 18-FEB-2010, the patient recovered. Follow-up information received from the medical assistant concerning the 9 weeks old female patient with no pertinent medical history and no illness at time of vaccination who on 18-FEB-2010, at 11:00 AM was vaccinated orally with the first dose of ROTATEQ (lot number 664783/1211Y). The patient gagged and vomited when a few drops of the vaccine was administered orally; the patient vomited again when full dose administered. The patient was administered a second dose of vaccine because the medical assistant was not aware of not needing to re-administer dose. The patient then was given injectables for PENTACEL, RECOMBIVAX HB (manufacturer unspecified) and PREVNAR IM without incidence. The patient and her parents left the office after the injectables were given; the patient seemed okay. Additional information is not expected. This is an amended report. The AE term "inappropriate schedule of drug administration " has been removed from this case.
This case was reported by a other health professional and described the occurrence of extra dose administered in a 23-month-old male patient who received HAVRIX pediatric (batch number AHAVB286BA, expiry date 21st March 2006). Previously administered products included HAVRIX pediatric. On 2nd September 2009, the patient received the 3rd dose of HAVRIX pediatric. On an unknown date, an unknown time after receiving HAVRIX pediatric, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown. It was unknown if the reporter considered the extra dose administered to be related to HAVRIX pediatric. Investigator comments: HAVRIX given to a child on 05 November 2008, 29 April 2009 and 02 September 2009. State registry and EMR now flagging Hep A dose needed.
Cellulitis nfection occured at the injection site of the left arm within 24 hours of the vaccination on 9/24/20 at 12:30pm.  I experience red inflammation of the arm, size os redness was 4 inches by 4 inches.  The site was hard and was extremely hot to the touch.  Alos, it is noted that the shot was given too low on the arm and was not fully administered into the muscle properly.
woke up around 12:00 w/ h/a & vomiting; woke arm was bruised w/2 quarter sized welts on each side of inj site;states arms is so sore it is difficult to lift it;
14 year old that was given a dose of the Moderna vaccine; 14 year old that was given a dose of the Moderna vaccine, received Pfizer COVID-19 vaccination as the primary series; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old that was given a dose of the Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (14 year old that was given a dose of the Moderna vaccine, received Pfizer COVID-19 vaccination as the primary series) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 vaccination (patient received Pfizer COVID-19 vaccination as the primary series). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccination.    On 24-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old that was given a dose of the Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (14 year old that was given a dose of the Moderna vaccine, received Pfizer COVID-19 vaccination as the primary series). On 24-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old that was given a dose of the Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (14 year old that was given a dose of the Moderna vaccine, received Pfizer COVID-19 vaccination as the primary series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.  Patient was 5feet 10 inches. The Lot number and expiration date for the Pfizer COVID-19 vaccine were unknown
Pt came in to receive vaccines that she was behind on, per her  schedule she needed DTaP/DT/TD/Tdap, Hep-B and IPV. Pt was given DTaP because she has only received 2 prior to doses however per schedule pt should have been given Tdap because of her age. Orders were given by provider to give DTaP.
A report received from a health care professional on 10/25/2002, concerning a 2 year old vaccinee of unknown sex who inadvertently received 0.25ml  of Fluvirin vaccine on 10/25/2002/. The vaccinee experienced no adverse reaction. There was insufficient information to determine the reporters causality assessment. Update1. 12/10/2002: A report was received from a health care professional which indicated that the vaccinee was a 32 month old male when he received Fluvirin vaccine.
This is a spontaneous report from a contactable consumer (Patient) and Pfizer oncology together. A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6206), via an unspecified route of administration in left arm on 09Mar2021 at 11:05 (at the age of 73-year-old) as dose 1, single for COVID-19 immunisation; sunitinib malate (SUTENT), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 50 mg for an unspecified indication. Medical history included bifocals user from an unknown date and unknown if ongoing, stent placed in left leg from an unknown date in 2019 and ongoing (Embossed stent placed in left leg about 1.5 years ago. He did not have a very good experience, he coded), Old brain does not function very good from an unknown date and unknown if ongoing (used to be sometimes, now it was all the time), blood pressure from an unknown date and unknown if ongoing. Concomitant medications included cetirizine at 10mg taken daily as needed for allergies from an unknown date in 2016 and unknown if going (started probably 5 years ago or so), simvastatin for an unknown indication from an unknown date in 2016 and unknown if going (started probably 5 years ago or so), hydrochlorothiazide for an unknown indication from an unknown date in 2016 and unknown if going (started probably 5 years ago or so), nifedipine for blood pressure from an unknown date in Jan2016 and unknown if going (started probably 5 years ago or so), metaprolol for blood pressure from an unknown date in Jan2016 and unknown if going (started probably 5 years ago or so), baby aspirin at 81mg tablet taken every day for clotting he believes from an unknown date and unknown if ongoing (started probably 5 years ago or so), multivitamin at 1 (unknown units and dosage form) taken daily for supplement from an unknown date and unknown if ongoing (started probably 5 years ago or so). The patient did not receive any other vaccines within four weeks prior to the vaccination. This consumer was administered his first dose of Pfizer-BioNTech COVID-19 Vaccine on 09Mar2021. He had some pretty bad reactions he believes, because they have never happened to him before. He asked if these pretty bad reactions are a sign that he should not get the second dose of the Pfizer-BioNTech COVID-19 Vaccine. Further described to include chills, hives, weakness, and sharp pain in left ankle. Chills started evening of 09Mar2021 at unknown time. Then the hives, weakness and sharp pain in left ankle started on 10Mar2021 at unknown time. He reported event was improved, he took some Tramadol and events eased up. The adverse events were not resulted in emergency room nor physician office and not hospitalized. The investigation assessment was reported as yes. The patient underwent lab tests and procedures which included lab work was unknown, not resulted yet on 10Mar2021. The outcome of the events was reported as resolving. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s): US-PFIZER INC-2020001462 same patient.
02//25/2021 (day of vaccination-starting 2 hours after injection) had intense pain, discomfort in left arm vaccinated and was unable to move arm without pain, which also did not allow me to sleep that night (no pain relievers taken) and chills. Next day, 02/26/2021, arm pain still intense along with loose stool, nausea for about 1/2 hour, as well as entire day of fatigue, fever about 3 degrees above normal, no appetite, lethargy, chills.  2/27/2021 had diarrhea, lethargy, and no appetite as well as lessening of sore arm, no appetite, and no fever.
RED AND SWOLLEN ABOUT 4X4 AREA OVER SITE OF VACCINATION. DID CALL PATIENT ON 11/1 AND HE SAID THAT REDNESS AND SWELLING WAS GOING DOWN.
I had a racing heart for over 24 hours (85-95 bpm) as well as extreme tiredness, headache, and body aches.  I could not really leave bed for more than a day.  My heart rate remained elevated for almost a week after until returning back to normal around 60.
Patient received second dose of bivalent Moderna, and 2nd dose dose of flu (for the season) when their screening questions indicate they were up to date already.
Information has been received from a registered nurse concerning a 17 week old male with no medical history or allergies who on 20 Dec 2006 was vaccinated with an oral dose of Rotateq (lot 655175/0849F). There was no concomitant medication. On 20 Dec 2006 the patient vomited instantly after vaccination. Unspecified medical attention was sought. No laboratory diagnostic test were performed. The patient recovered the same day. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2007. Information has been received from a registered nurse concerning a 17 week old male with no medical history or allergies who on 20-DEC-2006 was vaccinated with second oral dose of ROTATEQ (lot #655175/0849F). Concomitant vaccination administered that same day included a second IM dose in the left thigh of DAPTACEL (lot #C2650AA), a second IM dose in the left thigh of ACTHIB (lot #UE844AA), a second SC dose in teh right thigh of IPOL (lot #20018) and a second IM dose in the right thigh of PREVNAR (lot #B085708). On 20-DEC-2006 the patient vomited instantly after vaccnation, prior to receiving other vaccinations. Unspcified medical attention was sought. No laboratory diagnostic test were performed. The patient recovered the same day. It was noted that the patient was held for the first dose of ROTATEQ and was lying down for the second dose of ROTATEQ. There was no product quality complaint involved. Additional information is not expected.
No adverse events. Dose given was Maroon cap mixed with 1.3ml instead of 2.2ml
6PM 14AUG91 fever 104.2, 15AUG91 3AM t105, malaise, anorexia, some irritability; 15AUG91 local rxn @ inject site red & swollen 6in circumference; Dusky color to knee; Had runny nose & swollen glands for 12 hrs; Devel fine rash;
Phone call - Employee stated  received an MMR on 1-16-09 and on 1-20-09 started itching in entire body and having facial swelling.
Presented with cough/SOB, fever, sore throat; DX Covid PNA; CXR: infiltrates and consolidation LABS: D-dimer: 0.65; CRP: 22.86; Ferritin: 453; Tx: doxycycline, rocephin, decadron, remdesivir,  zinc, singulair, Vit C, Vit D, Baricitinib, Lovenox, antitussives, bronchodilators; Intially on 4LPM O2; 1/27 O2 req up to Bipap, FiO2 100%; 1/28 to ICU for resp support/monitoring; 2/6 FiO2 down  to 6LPM NC; 2/7 Out of ICU; d/c to LTAC; remains on 6 LPM O2
Patient received her 2nd dose of the Moderna vaccine with 0.4ML dose by mistake; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient received her 2nd dose of the Moderna vaccine with 0.4ML dose by mistake) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .4 ml. On 08-Feb-2021, the patient experienced ACCIDENTAL UNDERDOSE (Patient received her 2nd dose of the Moderna vaccine with 0.4ML dose by mistake). On 08-Feb-2021, ACCIDENTAL UNDERDOSE (Patient received her 2nd dose of the Moderna vaccine with 0.4ML dose by mistake) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was given. No concomitant medications were reported.  This report refers to a case of accidental underdose for mRNA-1273 with no associated AEs.   This case was linked to US-MODERNATX, INC.-MOD-2021-013253 (E2B Linked Report).; Sender's Comments: This report refers to a case of accidental underdose for mRNA-1273 with no associated AEs.
COVID-19; Sleep apnea; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and SLEEP APNOEA SYNDROME (Sleep apnea) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced COVID-19 (COVID-19) and SLEEP APNOEA SYNDROME (Sleep apnea). At the time of the report, COVID-19 (COVID-19) and SLEEP APNOEA SYNDROME (Sleep apnea) was resolving.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.   The reporter's causality for the events of sleep apnea and COVID-19 with Humira (adalimumab) was no reasonable possibility. The reporter assessed events of sleep apnea and COVID-19 as possibly related to Moderna COVID-19 vaccine.  No treatment details were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report as received from a 66 years old female consumer with no pertinent medical history or drug reactions/allergies, reporting on herself. The patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (dose #, and lot not reported) subcutaneously or intramuscularly on 22-OCT-2012. Concomitant medications included: unspecified heart medications, "FLEXIX", lovastatin and omeprazole. On 22-OCT-2012, at night, her injection site arm was hot and sore. On the next day, it was still sore and hot, her temperature was 99.8 degrees. The soreness moved toward elbow, exhibiting a sunburn appearance. Her elbow felt tight and sore, and the patient also had eye pain. On 24-OCT-2012, her temperature was 99.5 degrees. The patient called the pharmacist for medical attention. The patient self medicated with over the count TYLENOL. There were no labs/diagnostic studies performed. The outcome of the events was reported as not recovered. The relationship between PNEUMOVAX 23 and the events was not reported. Additional information has been requested.
TWO DAYS AFTER VACCINATON SYMPTOMS WERE HEADACHE & LETHARGY & CHILLS-TOOK TEMPERATURE NEXT MORNING....102---AFTER TYLENOL WENT TO 101.. WENT TO 100 AFTER 4 HOUR DOSE OF OTC TYLENOL- ONE TABLET 500 MG
Presents stating that yesterday he received an influenza vaccine in his left arm. States as the vaccine was being injected he felt a "pop" and felt like "fluid built up". Believes it was given too high up on his arm. By later in the day he felt like he could feel fluid moving around in his arm from shoulder distally to his mid upper arm.  Felt aching "deep" in his shoulder. Today feels a dull ache from his shoulder into his left clavicle area in addition to the more typically expected arm soreness following a vaccine. Has full ROM of arm. Plans to observe carefully for changes. Unsure if he will seek further medical care at this time.
I have gotten Moderna vaccines that I got, I had no side effects other than a minor sore arm for one day; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (I have gotten Moderna vaccines that I got, I had no side effects other than a minor sore arm for one day) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (I have gotten Moderna vaccines that I got, I had no side effects other than a minor sore arm for one day). The patient was treated with VITAMIN D NOS at an unspecified dose and frequency; CALCIUM at an unspecified dose and frequency; MAGNESIUM at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (I have gotten Moderna vaccines that I got, I had no side effects other than a minor sore arm for one day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Every test that they took for blood sugar, Cholesterol, every test they had was in the normal range, there was nothing abnormal in the blood test..         Concomitant product use was not provided by the reporter.  On 25-Sep-2023, the patient received TOZINAMERAN (COMIRNATY) for an unknown indication and on an unknown date, received INFLUENZA VACCINE for an unknown indication. This was the first vaccine gotten of Pfizer.  The patient reported for the Pfizer COVID-19 Vaccine. Received the dose on 25-Sep-2023 and 3 days after started experiencing joint pain which still has today at the time of report.  The patient was taking Vitamin supplements, Vitamin D, Calcium, Magnesium, Vitamin C and I am taking Ibuprofen and extra strength Tylenol.  Lab work: The patient had a complete physical about a week and half ago had a complete lab, for blood sample.  Treatment information included Ibuprofen and Naproxen which, 3 months ago he had a shoulder surgery that the doctor wanted patient to take the Ibuprofen as part of his therapy.  Anatomical location of administration of Pfizer was right arm.  The patient has had several Moderna vaccinations, had the original, then had a booster and then had another booster and this says that it was a Moderna COVID-19 vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-747830 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747830:Monovalent case
fever of 100 to 101; Congestion; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients. This is the 2nd of the two reports.   A 79-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date: unknown), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 Immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the COVID-19 vaccine on 09Jan2021 and started having fever and congestion on 14Jan2021. The patient began to have a fever of 100 to 101 and congestion yesterday, 14Jan2021. The reporter stated she is giving her husband Coricidin and Vit C with Zinc and is taking her husband to see a healthcare professional (HCP). The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046098 Same reporter/drug/event; different patient.