chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adevrse Event; After receiving that dose of the vaccine he has not had to receive any additional doses of Retacrit, which he used to take at a monthly dose of 2000mL.; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (After receiving that dose of the vaccine he has not had to receive any additional doses of Retacrit, which he used to take at a monthly dose of 2000mL.) and NO ADVERSE EVENT (No Adevrse Event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. Unknown) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:N-stage kidney failure, dementia, heart transplant.  The patient's past medical history included Dementia, Kidney failure and Heart transplant. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine; for Product used for unknown indication: Retacrit (monthly dose of 2000mL) and monoclonal antibody treatment. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Retacrit and monoclonal antibody treatment.    In September 2022, 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. In 2022, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (After receiving that dose of the vaccine he has not had to receive any additional doses of Retacrit, which he used to take at a monthly dose of 2000mL.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adevrse Event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (After receiving that dose of the vaccine he has not had to receive any additional doses of Retacrit, which he used to take at a monthly dose of 2000mL.) and NO ADVERSE EVENT (No Adevrse Event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.   On an unknown date, the reporter stated that her husband received all Moderna vaccines.  On Sep-2022, the reporter stated that her husband received a dose of the bivalent vaccine. After receiving that dose of the vaccine her husband had not had to receive any additional doses of Retacrit, which he used to take at a monthly dose of 2000mL.  The reporter added that her husband also received a monoclonal antibody treatment about 1 month before this dose and had not been diagnosed with COVID-19.
On 9th day after vaccination, patient had difficulty urinating. Patient was hospitalized the following day. While hospitalized patient lost sensation in lower half of body. Information from Discharge summary states viral infection, myelitis, urine incontinence. msv
Soreness at injection site; pain in the muscle; pain in the muscle & shoulder joint; Fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Soreness at injection site"; MYALGIA (non-serious), outcome "unknown", described as "pain in the muscle"; ARTHRALGIA (non-serious), outcome "unknown", described as "pain in the muscle & shoulder joint"; PYREXIA (non-serious), outcome "unknown", described as "Fever".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Diarrhea; Gassiness; Soft stool; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA, FLATULENCE, and FAECES SOFT in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA, FLATULENCE, and FAECES SOFT. At the time of the report, DIARRHOEA, FLATULENCE, and FAECES SOFT outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product details not provided.  Treatment details not provided.
5 minute seizure occurred on 8/26, patient seen in ED and released with dx febrile seizure (T 103).  Pt. had another seizure about 3 hours later lasting 8 minutes with ~90 minute post-ictal period and was given lorazepam and phosphenytoin.  Then admitted for overnight observation; no further meds given.  Less active than usual for ~24 hours.  Was seen again today and is just returning to normal activity.  10/15/2007 MR received for DOS 8/26-27/2007 for DX:  Complex Febrile Seizures.  ALOM.  While eating child appeared pale and then developed GTC seizure which lasted ~4 minutes. Taken by EMS to ER where fever/OM was dxd and child was released.  About 1 hour later child had another GTC seizure lasting ~8 min which was still occuring upon arrival in ER.   PE (+) for small petechia R upper chest.  LTM dull, erythematous and retracted.Refusing to bear weight. Otherwise WNL.   No further seizures. D/C home next day.
About 6 hours after the vaccine, I experienced lip, eyelid and tongue swelling, numbness of lips.  Immediately took Benadryl 50 mg.  Improved after the Benadryl but did not resolve for 2.5 days. Retook Benadryl a few times in that period.  Resolved completely after that.
Had Shingrix vaccine #1 on 10-08-2020, no adverse reaction. Had second part of vaccine on 12-22-2020, on 12-23-2020, had a rash on abdomen approx 3/4 inch wide, 3 inches long, about 3 inches above navel. Rash was smooth as rest of skin, no itching or pain. On 12-27-2020, I noticed a tiny scabby spot on part of the rash. Ever since 12-28-2020, the entire rash has been scabby. Still have no itching or pain, BUT I AM CONCERNED THAT THIS MIGHT AFFECT MY ABILITY TO OBTAIN THE COVID VACCINE. I need to know if this kind of adverse reaction to the Shingrix vaccine is something I should be concerned about when I am able to get the COVID vaccine. I am in the high risk group, due to age and underlying medical conditions. I have not seen any medical professionals for this rash. Shingrix #1 administered 10-08-2020, no adverse reaction Shingrix #2 administered 12-22-2020, rash & irritation described above
Fever 100.7 - 101 lasted for 12 hours.  Headache, joint pain, fatigue, nausea.  These other symptoms subsided after many doses of tylenol, ibuprofin and  Aleve and sleeping for 11 hours on 4/10/2021,
1100: patient with c/o numbness and tingling of right side of tongue.  Physician on duty ordered 25mg Po Benadryl to be given.  Patient took Benadryl and refused water.   1110: Patient checked on by EMS on Duty with no changes. 1120: No changes to mouth noted still for patient.   1130: Still no changes, EMS on duty cleared patient for discharge home after 30 minutes of observation.  Informed patient to seek immediate medical attention if symptoms should worsen. Patient communicated understanding.
Within 2 hours I experienced tinnitus in both ears and it has been active ever since.
Headache, Myalgia, Fever, injection site pain Narrative:  Other Relevant History:
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ANGINA, UNSPECIFIED  5/14/2022  &  6/12/2022  --  RECURRENCE OF SAME SYMPTOMS
Full body rash, swollen neck & face, sensitivity to light, red & pussy eyes, lethargic, heat coming from body, but no fever. Rash lasted 2 weeks, swelling lasted 48 hrs., sensitivity to light for 4 to 5 days. Looked like the mini-measles.
a little swelling; Pain about a 1.5 or 2 out of 10; Fatigue; Insomnia; This spontaneous case was reported by a nurse and describes the occurrence of SWELLING (a little swelling), PAIN (Pain about a 1.5 or 2 out of 10), INSOMNIA (Insomnia) and FATIGUE (Fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history reported).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced INSOMNIA (Insomnia). On 24-Jan-2021, the patient experienced SWELLING (a little swelling), PAIN (Pain about a 1.5 or 2 out of 10) and FATIGUE (Fatigue). On 25-Jan-2021, PAIN (Pain about a 1.5 or 2 out of 10) and INSOMNIA (Insomnia) had resolved. At the time of the report, SWELLING (a little swelling) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered INSOMNIA (Insomnia) and FATIGUE (Fatigue) to be possibly related. No further causality assessments were provided for SWELLING (a little swelling) and PAIN (Pain about a 1.5 or 2 out of 10).    Treatment included Pt preemptively took 800 mg of ibuprofen about 1 hour prior to vaccination. No concomitant medications reported.    This case was linked to MOD-2021-018447 (Patient Link).
Pt vaccinated with DTP/OPV/HIB experienced 12 gran mal seizures which began 2 days after vaccines.
After my first vaccine, I experienced left arm soreness and fatigue. Two days later I experienced severe migraine headaches, nausea and dizziness. I take Humira medication for my Crohn's disease.
Swelling, redness, pain locally, extreme rt thigh. No care needed. Resolved.
No additional AEs were reported; The nurse practitioner reported that a patient received improperly stored vaccine on 9/20/2022; shipping delay; This spontaneous report was received from a nurse practitioner concerning a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 20-SEP-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot #W017551, expiration date: 01-JUN-2024 (dosage regimen, anatomical location and route of administration were not provided) administered as prophylaxis (product storage error).  The improperly stored vaccine underwent a temperature excursion of 77 degrees Fahrenheit (F) for 10 hours without previous excursions. No adverse events were reported.  Follow-up information has been received from the nurse practitioner and referred to a 17-year-old female patient on 02-NOV-2022. No other vaccine used within 4 weeks prior to the date of vaccination of varicella virus vaccine live (oka/merck) (VARIVAX). No adverse event following a prior vaccination. No pre-existing physician-diagnosed allergies, birth defects or medical conditions. The patient's concomitant vaccines (vaccinated on the same day with varicella virus vaccine live (oka/merck) (VARIVAX)) included hepatitis a vaccine inact (HAVRIX) (lot# 3397T) and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot# U031051). Upon review of packing slip (and placed into proper storage) and supervision (off site), it was noted that vaccine was to be delivered in by 19-SEP-2022 (considered it was the AE onset date of product distribution issue, but it was earlier than the vaccine start date, so just capture as September 2022 in field). When called Merck, they received stability data for varicella virus vaccine live (oka/merck) (VARIVAX) stored at room temperature for 10 hours. It was reported that varicella virus vaccine live (oka/merck) (VARIVAX) (lot# also reported as W017552 (inconsistent information: previous version reported as W017551), expiration date 01-JUN-2024; route subcutaneous (SQ), site was left arm, dose number 1) was administered after shipping delay and improper storage temperature (product storage error and product distribution issue). The patient received one dose of the vaccine at facility on 20-SEP-2022. No illness at time of vaccination. Manually activated indicated there was stability to support continued use of vaccine with shortened expiration date. Hence, there was a delivery issue, Merck asked a replacement shipment, and the original vaccine that was delivered late was returned to Merck. The patient was notified and did not experience any adverse reaction after the vaccine administration. It was reported called manufacturer discontinued used vaccine. It was reported the events product storage error and product distribution issue were attributable to the varicella virus vaccine live (oka/merck) (VARIVAX) (causality considered as related).
Soreness within 2 hours. Redness, swelling proximal to injection site within 24 hours. Instructed to ice, take BENADRYL and ibuprofen.
patient received MMRlI and VARIVAX approximately 40 days before becoming pregnant; No additional AEs reported; This spontaneous prospective pregnancy report as received from a physician referring to a female patient of unknown age. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dosage regimen, routes of administration, lot numbers and expiration dates were not provided) both for prophylaxis.    40 days later, the patient became pregnant (maternal exposure before pregnancy). The last menstrual period (LMP), estimated due date (EDD) and the pregnancy outcome were not known. No adverse event was reported.
Twitching I left eye. That has subsided After a few weeks. Still have Constant Twitching in left gluteus Maximus Same side as injected arm. Very annoying twitch.
Pneumonia; Thought it was bronchitis; COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PNEUMONIA (Pneumonia), BRONCHITIS (Thought it was bronchitis) and COVID-19 (COVID) in a 70-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), BRONCHITIS (Thought it was bronchitis) (seriousness criterion medically significant) and COVID-19 (COVID) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia), BRONCHITIS (Thought it was bronchitis) and COVID-19 (COVID) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was provided.  Company Comment: This is a spontaneous case concerning a 70- year-old, male patient with a history of COVID-19, who experienced the serious (due to medically significant) unexpected events of Pneumonia, Bronchitis and COVID-19. The events occurred on an unknown date after a dose of mRNA-1273 (Spikevax) (date of administration, dose number, prior doses, if applicable, and onset date were not provided; hence, latency could not be estimated). Clinical course, supportive diagnostic procedures and treatment were not provided. The outcome of the events was not reported. The events Pneumonia and Bronchitis were considered as not related to the vaccine due to lack of biological plausibility. The benefit-risk relationship of mRNA-1273 (Spikevax)  is not affected by this report.
delayed menstrual cycle >14 days for two cycles; very heavy bleeding and lasting for >1 week (both cycles); delayed menstrual cycle >14 days for two cycles; very heavy bleeding and lasting for >1 week (both cycles); delayed menstrual cycle >14 days for two cycles; very heavy bleeding and lasting for >1 week (both cycles); This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Dec2021 (Lot number: FJ1620) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, single, Previous dose lot number=EW0158, Previous dose vaccine location=Left arm), administration date: 21May2021, when the patient was 43 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, single, Previous dose lot number=EW0158, Previous dose vaccine location=Left arm), administration date: 30Apr2021, when the patient was 43 years old, for COVID-19 immunization.  The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), MENSTRUATION DELAYED (non-serious), OLIGOMENORRHOEA (non-serious) all with onset 19Jan2022, outcome "recovered" and all described as "delayed menstrual cycle >14 days for two cycles; very heavy bleeding and lasting for >1 week (both cycles)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of heavy menstrual bleeding, menstruation delayed, oligomenorrhoea.  Additional information: No other vaccine were received in four weeks. No other medications were received in two weeks. No covid prior vaccination. No Known allergies.  No follow-up attempts are possible. No further information is expected.
Within a few hours of receiving the vaccine, I started having muscle pain. This pain was unlike the aches I had previously had with previous doses of the Moderna Covid vaccine (with the second vaccine, I experienced achy muscles and a bad headache for 10 days. The headache never fully went away). This time it included sharp shooting pains in my neck, hands, forearms, torso, thigh, feet, hips, ankles, elbows and  knees. The pain is severe enough that it is difficult to walk or do daily tasks. Initially, I took Advil to try to address the pain, but it did very little. I went to my primary care doctor on January 20th who diagnosed me with muscle inflammation and gave me a steroid injection in my buttocks, as well as Toradol to try to relieve the pain. The Toradol did not help at all. It has been over five days since the steroid injection, but if there has been any improvement in the pain, it is very slight. I still have a lot of pain whether I am laying still or moving. I was required to receive the booster to return to college, or submit to weekly testing.
Pt recvd vax 23OCT92 & 1 wk later devel soreness, swelling, erythema @ the inject site in lt arm which lasted for approx 2 1/2 wks;
Swollen neck (left gland), fever, shivers,severe headache, difficulty breathing, sroe throat, muscle aches, cough and felt tired
This spontaneous report as received from a healthcare worker refers to a 17 year old female patient with no drug reactions or allergies and with no medical history. On 02-APR-2014 the patient was vaccinated intramuscularly with the first dose of GARDASIL (lot # J011960, expiration date 06-AUG-2015, dose not reported). Concomitant therapies included NUVARING. On 02-APR-2014 after receiving the first dose of GARDASIL the patient experienced seizure. The reporter stated that the patient fell out of the chair she was sitting in the office. The patient was taken to the hospital by the paramedics and was admitted. The outcome of seizure was unknown. The patient sought medical attention by being at the doctor's office. The relatedness between the therapy with GARDASIL and seizure was not reported. Upon internal review the event of seizure was determined to be medically significant. Additional information has been requested.
Pt fainted seconds after receiving the 1st Moderna vaccine.  Unconscious for approx. 30 seconds, shaking limbs & facial twitching.    Pt came too quickly & mother came to take him home without assistance.
DIFFICULTY IN BREATHING; SPLITTING HEADACHE; This spontaneous report received from a patient concerned a 32 year old female. 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 12-APR-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 APR-2021, the subject experienced difficulty in breathing. On APR-2021, the subject experienced splitting headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from splitting headache, and the outcome of difficulty in breathing was not reported. This report was non-serious.
No additional AE/PQC reported.; vaccine expired on 03/06/2023 and was administered to the patient on 03/10/2023.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 10-MAR-2023, the patient was inadvertently administered an expired dose of hepatitis a vaccine, inactivated (VAQTA) pre-filled syringe, 0.5 milliliter once, lot #W002894, expiration date: 06-MAR-2023 (lot number has been verified as valid for VAQTA) (strength, and route of administration were not provided) as prophylaxis (expired product administered). No adverse event was reported.
on 23-Feb-2022, an IPOL vaccine was administered to a 4 year old. It was later noted that the vaccine had expired on 25-Jan-2022, with no reported adverse event; Initial information received on 25-Feb-2022 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 4 years old female patient to whom on 23-feb-2022, an ipol vaccine was administered, it was later noted that the vaccine had expired on 25-Jan-2022, with no reported adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria vaccine toxoid, Pertusis vaccine acellular, Tetanus vaccine toxoid (DTAP) for Prophylactic vaccination.  On 23-Feb-2022, the patient received 0.5mL dose of suspect IPV (VERO) vaccine suspension for injection once (lot number: T1D48 and expiry date: 25-Jan-2022) via intramuscular route in an unknown administration site for immunization.  On 23-FEB-2022 the 4 year old patient was given an ipol vaccine, it was later noted that the vaccine had expired on 25-Jan-2022, with no reported adverse event (expired product administered) (latency: same day) following the administration of IPV (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event (expired product administered).  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 guidelines. 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.